Early discharge with home support of gavage feeding for stable preterm infants who have not established full oral feeds

Collins CT, Makrides M, McPhee AJ

Background - Methods - Results - Characteristics of Included Studies - References - Data Tables & Graphs


Cover sheet

Title

Early discharge with home support of gavage feeding for stable preterm infants who have not established full oral feeds

Reviewers

Collins CT, Makrides M, McPhee AJ

Dates

Date edited: 29/01/2004
Date of last substantive update: 14/07/2003
Date of last minor update: 15/07/2003
Date next stage expected 30/08/2004
Protocol first published: Issue 3, 2002
Review first published: Issue 4, 2003

Contact reviewer

Ms Carmel T Collins
Research Nurse/Midwife
Dept Nursing & Midwifery Research & Practice Development
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia AUSTRALIA
5006
Telephone 1: 61 8 8161 6434
Telephone 2: 61 8 8161 7000
Facsimile: 61 8 8161 7704
E-mail: collinsct@wch.sa.gov.au

Contribution of reviewers

CTC developed the protocol and wrote the review with contributions from MM and AJM. CTC and MM assessed articles for inclusion and extracted the data.

Internal sources of support

Dept Nursing & Midwifery Research & Practice Development, Women's & Children's Hospital, North Adelaide, SA, AUSTRALIA
Child Health Research Institute and Dept Paediatrics, The University of Adelaide, Women's & Children's Hospital, North Adelaide, SA, AUSTRALIA
Neonatal Medicine, Women's & Children's Hospital, North Adelaide, SA, AUSTRALIA

External sources of support

Salary for Maria Makrides was drawn from a RD Wright National Health and Medical Research Council Fellowship, AUSTRALIA

What's new

Dates

Date review re-formatted: / /
Date new studies sought but none found: / /
Date new studies found but not yet included/excluded: / /
Date new studies found and included/excluded: / /
Date reviewers' conclusions section amended: / /
Date comment/criticism added: / /
Date response to comment/criticisms added: / /

Text of review

Synopsis

Synopsis pending.

Abstract

Background

Early discharge of stable preterm infants still requiring gavage feeds has the potential benefits of uniting families sooner and reducing health care and family costs compared to discharge home when on full sucking feeds. Potential disadvantages include the increased burden for the family and the possibility of complications related to gavage feeding.

Objectives

To determine the effects of a policy of early discharge of stable preterm infants with home support of gavage feeding compared with a policy of discharge of such infants when they have reached full sucking feeds.

Search strategy

The standard search strategy of the Cochrane Neonatal Review Group was used together with additional searches of the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003), CINAHL (1982 to April week 1 2003), EMBASE (1980 to 2003 week 15) and MEDLINE (1966 to April week 1 2003).

Selection criteria

All randomised and quasi-randomised trials among infants born <37 weeks and requiring no intravenous nutrition at the point of discharge were included. Trials were required to compare early discharge home with gavage feeds and health care support with later discharge home when full sucking feeds were attained.

Data collection & analysis

Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group.

Main results

Data from one quasi-randomised trial, with 88 infants from 75 families, were included in the review. Infants in the early discharge program with home gavage feeding had a mean hospital stay that was 9.3 days shorter [MD -9.3 (-18.49 to -0.11)] than infants in the control group. Infants in the early discharge program also had a lower risk of clinical infection during the home gavage period compared with the corresponding time in hospital for the control group [RR 0.35 (0.17 to 0.69)]. There were no significant differences between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage program or from hospital, scores reflecting parental satisfaction, or health service use.

Reviewers' conclusions

Experimental evidence to evaluate the benefits and risks in preterm infants of early discharge from hospital with home gavage feeding compared with later discharge upon attainment of full sucking feeds is limited to the results of one small quasi-randomised controlled trial. High quality trials with concealed allocation, complete follow-up of all randomised infants and adequate sample size are needed before practice recommendations can be made.

Background

A commonly accepted criterion for discharge of physiologically stable preterm infants is that gavage (tube) feeds are no longer required (AAP 1998). The last one to two weeks of hospitalisation for stable infants is used primarily for the provision of gavage feeds during their transition to full sucking feeds, along with education and support for parents.

Reducing the length of hospitalisation for preterm infants has been suggested to have positive emotional and psychological benefits for the family (Laddem 1992) and for the infant's development (Casiro 1993). Randomised controlled trials have shown that 'early discharge' of physiologically stable preterm infants based on a set weight criterion is safe and cost effective (Cruz 1997; Casiro 1993; Brooten 1986; Lefebvre 1982). However, to be eligible for inclusion in these studies the infants had to be gaining weight satisfactorily on full sucking feeds.

The discharge of physiologically stable preterm infants who still need gavage feeds has been reported (Evans 1988; Wakefield 1994; Evanochko 1996; Swanson 1997). This model of care is based on the premise that graduation to full sucking feeds can be undertaken successfully at home with health care support. The potential benefits of this model of care are that by uniting the family earlier there may be a positive impact on the infant's development; and there would also be a reduction in costs to the health service and family. The potential disadvantages arise from the possibility for an increased burden on the family with this higher level of care, and the possible complications associated with gavage feeding, for example growth failure and aspiration pneumonia.

Descriptions of home gavage feeding programs all provide some form of follow-up until gavage feeding is no longer required and there is adequate weight gain. The types of health care support described include outpatient clinic visits with hospital and/or parent-initiated telephone calls (Evans 1988; Evanochko 1996); home visits as considered necessary by the nurse or as requested by the mother; health caretaker-initiated telephone calls; and 24 hour emergency phone contact for parents (Wakefield 1994; Swanson 1997).

All studies reported that early discharge with home gavage feeding for stable preterm infants was safe in terms of adequate weight gain, and no infants required readmission (Evans 1988; Wakefield 1994; Evanochko 1996; Swanson 1997). Swanson 1997 reported a reduction in hospital stay of 9.3 days from the birth weight category average. Anecdotal responses from parents about the home gavage feeding programs were positive (Evans 1988; Wakefield 1994; Evanochko 1996; Swanson 1997). The studies, however, were small and uncontrolled, with poorly defined outcomes.

It is important that the safety of early discharge with home gavage feeding for stable preterm infants is established. It is also important to establish the effect on the family of this increased level of care. The conduct of a systematic review to assess current evidence is warranted.

Objectives

To determine the effects of a policy of early discharge of stable preterm infants with home support of gavage feeding compared with a policy of discharge of such infants when they have reached full sucking feeds.

Sub-group analyses were planned to determine if safety and efficacy outcomes are altered by the type of support received (outpatient visits versus home support) or the maturity of the infants (gestational age <= 28 weeks at birth or birth weight <=1000 grams).

Criteria for considering studies for this review

Types of studies

All trials using random or quasi-random patient allocation.

Types of participants

Infants born less than 37 weeks gestation and requiring no intravenous supplementation at the point of discharge. Infants requiring supplemental oxygen may be included.

Types of interventions

Early discharge home with gavage feeds and health care support, versus later discharge home when full sucking feeds are attained. Studies that don't include any aspect of home support for home gavage feeding will be excluded.

Types of outcome measures

Primary efficacy outcomes:
1. Feeding and growth outcomes as assessed by:
1.1 number of days to reach full sucking feeds
1.2 breast feeding prevalence (any and fully) on discharge and at 3 and 6 months post discharge. To be defined as fully breast feeding no other liquid or solid is given to the infant apart from vitamins, minerals, water, juice or ritualistic feeds given infrequently (Labbok 1990).
1.3 weight gain
1.4 length of hospitalisation
1.5 neurodevelopmental outcome at 12 months

Primary safety outcomes:
2. Re-admission
2.1 rehospitalisation during the period of home gavage feeding
2.2 rehospitalisation (excluding home gavage period) in the first year post discharge

3. Adverse events
3.1 milk aspiration - on radiologic assessment
3.2 infection during period of gavage feeding
3.3 death within the first year post discharge

Secondary outcomes:
1. Satisfaction
1.1 Parental satisfaction as measured by self report, including assessment of key elements of such programs, e.g. education

2. Cost
2.1 Cost comparison from trial entry to discharge from hospital or home support for both the hospital and family. For the home gavage group: cost of home support (home visits, phone calls). For those discharged on full sucking feeds: cost of extra hospital stay, cost to parents of visiting - e.g. travel costs).

3. Health service use
3.1 Other health service use post discharge from hospital or home support (includes visits to physician, outpatient clinics or emergency department)

Search strategy for identification of studies

The search strategy was initially to be centred around gavage tube feeding and early discharge. It was necessary however, to broaden the search to include all trials of early discharge programs for preterm infants as gavage feeding may have been included as one component of an early discharge program.

See: Cochrane Neonatal Group search strategy. The standard search strategy of the Cochrane Neonatal Review Group was used.

Literature searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2003), MEDLINE (1966 to April Week 1 2003), CINAHL (1982 to April Week 1 2003) and EMBASE (1980 to 2003 Week 15) databases were undertaken.
The free text terms used were 'early discharge', 'hospital in the home', 'random$', 'gavage', 'gavage feed$', 'tube feed$'. The MESH terms used included: infant low birth weight, infant premature, infant premature diseases, patient discharge, home care services, home nursing, length of stay, enteral nutrition, randomised controlled trials, random allocation, double blind method, single-blind method, clinical trials. The search was not restricted by language.

Methods of the review

Standard methods of the Cochrane Collaboration (Clarke 2003) and the Cochrane Neonatal Review Group were used.

Selection of studies for inclusion
Studies were excluded if it was apparent from the abstract that they did not meet the inclusion criteria as assessed by one reviewer (C Collins). Where there was uncertainty about inclusion of the study, the full text was retrieved. Two reviewers (C Collins, M Makrides) independently assessed the full text articles for inclusion. If there was disagreement between reviewers about the studies to be included that could not be resolved by discussion, assistance from the third reviewer was sought.

Assessment of methodological quality
Once inclusion of trials had been agreed, the methodology of the trial was assessed. The data were extracted onto hard copy data sheets. Data extraction and quality assessment were made by C Collins and M Makrides. The standard methods of the Neonatal Review Group were used to assess the methodological quality of the included trials. These included assessing the trial for blinding of randomisation, blinding of intervention, completeness of follow up and blinding of outcome measurement.

Additional information was requested from Gibson 1998 for outcome data on the sub-group of infants discharged home gavage feeding. Additional information was also requested from Ortenstrand 1999 on: breast feeding outcomes; blinding of outcome assessment; length of hospitalisation; health service use. Verification of the inclusion criterion concerning feeding status was requested for three trials (Davies 1979; Dillard 1973; Puerto 1993).

Analysis
Analyses for treatment effect were conducted on an intention-to-treat basis. Relative risk and risk difference with 95% confidence intervals were calculated for dichotomous data. Mean difference with 95% confidence intervals were used for outcomes measured on a continuous scale.

Description of studies

Twelve trials were identified. Seven trials of early discharge programs were excluded because all infants were on full sucking feeds before discharge home (Bhargava 1980; Brooten 1986; Casiro 1993; Charpak 1997; Cruz 1997; Finello 1998; Lefebvre 1982). Feeding status on discharge home was not described in three trials (Davies 1979; Dillard 1973; Puerto 1993). The authors of these trials have confirmed that infants in their study were on full sucking feeds before discharge home (Dillard 1973; Davies 1979; Puerto 1993) and these trials were therefore excluded.

Gibson 1998 conducted a randomised controlled trial of a home supported early discharge program. Infants were eligible for the study if birth weight was less than or equal to 1800 grams and gestational age was <36 weeks at birth. Exclusion criteria included infants with congential abnormalities, severe apnoea, neurological impairment, feeding intolerance, or an unwilling or incapable caregiver, unsafe home environment or home care services inaccessible. Infants in the experimental group were discharged home at approximately 1800 grams if certain clinical criteria were met, one of which was "infant tolerating full feedings, either via gavage or nipple" (p S18). The control group were discharged home according to routine hospital policy including the requirement to be on full sucking feeds. The authors have not reported the proportion of infants that received home gavage feeds. In a published abstract describing the first 50 infants enrolled in their study (Gibson 1996) five infants (10%) were discharged home requiring gavage feeds. The final sample size for the study was 100 infants (Gibson 1998); if the trend for proportion discharged home on gavage feeds continued then ten infants would have been so. It may be possible to include data from this study if the authors have separate subgroup analyses for the outcomes of those who were discharged home on gavage feeding. Data from this study will be considered for inclusion when available from the authors.

In the study of Ortenstrand 1999, the majority of infants in the experimental group (80%) were discharged home still requiring gavage feeds (n=36/45). The inclusion criteria for this systematic review was 'early discharge home with gavage feeds and health care support versus later discharge home when full sucking feeds are attained'. Given the difficulty in locating studies specifically designed to assess home gavage feeding we have decided to include this study, even though 20% (9/45) of the infants in the experimental group did not receive home gavage feeds. The nine infants who did not receive home gavage feeds were discharged to the program and received home visits. They were discharged from the program when the ordinary criteria for hospital discharge were met, i.e. clinically well and gaining weight satisfactorily on full sucking feeds. These nine infants were included in the analysis for this systematic review.

For the purposes of this review the experimental group will be referred to as the home gavage program.

This review, therefore, includes one quasi-randomised controlled clinical trial (Ortenstrand 1999) from which there are two publications.

Participants
This single centre Swedish study involved 88 infants from 75 families (45 infants/40 families - experimental, 43 infants/35 families - control). Participants were preterm infants with a mean gestational age at birth of 31.4 weeks (SD 2.8) in the experimental group and 32 weeks (SD 2.3) in the control. 70% (23/40) of mothers in the experimental group were primiparous and 60% (21/35) in the control group. There were five pairs of twins in the experimental group (10/45, 22%) and eight in the control (16/43, 37%).

Interventions
This trial compared early discharge with home visits by a registered nurse for infants still requiring special care (mainly gavage feeds) with standard care (discharge home when clinically well and gaining weight satisfactorily on full sucking feeds). The large majority of the infants in the early discharge group were discharged home still requiring gavage feeds (36/45, 80%). Infants were discharged from the home program when the ordinary criteria for hospital discharge were met, i.e. clinically well and gaining weight satisfactorily on full sucking feeds.

Study entry occurred when infants met the inclusion criteria listed in the table of included studies. On study entry, infants in the experimental group (allocated to the home program) had a mean postmenstrual age of 35.9 weeks, SD 1.6 and infants in the control group (who remained in hospital) had a mean postmenstrual age of 35.6 weeks, SD 1.2.

Outcome measures and results
The end of the intervention was discharge from the home gavage program for the experimental group and discharge from hospital for the control group. There was no significant difference in postmenstrual age at the end of study intervention (experimental 38.7 weeks, control 38.6 weeks). The trial measured breast feeding outcomes, weight gain, rehospitalisation, infection (clinical signs), health problems, medications, home visits, telephone calls, visits to neonatal ward, travelling time for nurse, health service use during first year post discharge, confidence in handling baby, experiences relating to care, experiences relating to infants' health and parental anxiety.

For further details see Table: Characteristics of Included Studies.

Methodological quality of included studies

Details of the methodological quality of the study are available in the Table: Characteristics of Included Studies.

Randomisation: After discussion and consultation it was agreed to accept the Ortenstrand 1999 study as a quasi-randomised controlled trial. The nursery in the trial had two separate rooms with separate teams of nursing staff, the rooms were randomly designated as experimental or control. Allocation of infants to the control or experimental group was based on bed availability. The authors report that the unit was constantly busy and the opportunity to choose between the rooms was "almost never an option" (Ortenstrand 1999, p 1025). To minimise the potential for the hospital nursing teams to affect outcomes the designation of experimental room and control room was changed after an eight month period. Due to the potential for selection bias the blinding of randomisation was classified inadequate.

Blinding of treatment: not possible

Exclusions after randomisation: 7% for primary outcomes, 14% for secondary outcomes

Blinding of outcome assessment: yes

Results

One study contributed data to this review (Ortenstrand 1999).

Primary outcomes

1. Feeding and growth
1.1 Days to reach full sucking feeds
Not reported.

1.2 Breast feeding (outcome tables 01 and 02)
Breast feeding outcome data were reported only for those who completed the one year follow up (experimental group n=41, control group n=41). There were no statistically significant differences between the experimental and control groups in the proportion of infants who had stopped any (fully and partially) breast feeding at any time points. By the time of discharge from the home gavage program (experimental) or discharge from hospital (control), 2/41 of the home gavage group and 4/41 of the control group had stopped breast feeding [RR for stopping breast feeding 0.50 (0.10 to 2.58)]. At three months post discharge from the home gavage program (experimental) or post-discharge from hospital (control), 8/41 of the home gavage group and 5/41 of the control group had stopped breast feeding [RR 1.60 (0.57 to 4.48)]. At six months post discharge from the home gavage program (experimental) or post-discharge from hospital (control), 20/41 of the home gavage group and 12/41 of the control group had stopped breast feeding [RR 1.67 (0.94 to 2.95)].

The outcome fully breast feeding was compared to a combined group of partially and not breast feeding. No significant differences were found in the proportion of infants not fully breast feeding in the home gavage group (experimental) compared with the control group at any time points. On discharge from the home gavage program (experimental) or discharge from hospital (control), 13/41 of the home gavage group and 10/41 of the control group were not fully breast feeding [RR for not fully breast feeding 1.30 (0.64 to 2.62)]. At three months post discharge from the home gavage program (experimental) or post-discharge from hospital (control), 8/41 of the home gavage group (experimental) and 6/42 of the control group were not fully breast feeding [RR 1.33 (0.51 to 3.50)]. At six months post discharge from the home gavage program (experimental) or post-discharge from hospital (control), 24/41 of the home gavage group (experimental) and 24/41 of the control group were not fully breast feeding [RR 1.00 (0.69 to 1.44)].

1.3 Weight gain (outcome table 03)
Weight gain was assessed from trial entry until discharge from the home gavage program (experimental), and from trial entry to discharge from hospital (control). No significant difference was detected in weight gain [MD -1.10 g/day (-3.94 to 1.74)].

1.4 Length of hospitalisation (outcome table 04)
Infants in the home gavage program had a mean hospital stay that was 9.3 days shorter [MD -9.30 (-18.49 to -0.11)] than infants in the control group. Infants in the home gavage program spent a mean of 19.6 days (SD 9.2 days) on the home program.

1.5 Neurodevelopmental outcome at 12 months
Not assessed

2. Hospital re-admission (outcome table 05)
2.1 During period of home gavage feeding
8/45 infants were rehospitalised nine times during the home gavage program (two infants for jaundice, two for blood transfusion, one for inguinal herniorrhaphy and cryotherapy of retinopathy, one for observation prior to removal of apnoea monitor, one for a skin condition and maternal anxiety, and one for respiratory syncytial virus infection).

2.2 Re-admission within first 12 months post discharge from home gavage program or from hospital.
Data on re-admissions post discharge from the home gavage program or from hospital were reported only for those who completed the one year follow up (experimental group n=41, control group n=41). There were no significant differences between groups in the proportion of infants who had one or more re-admissions during this period [RR 1.09 (0.54 to 2.18)]. 12/41 were readmitted 19 times in the home gavage group (median 0, range 0-5) and 11/41 infants readmitted 22 times in the control group (median 0, range 0-7).

3. Adverse events (outcome table 06)
3.1 Milk aspiration on radiologic examination
Not reported.

3.2 Infection during period of home gavage and corresponding time in hospital
Infants in the home gavage program had a lower risk of infection during the home gavage period compared with the corresponding time in hospital for the control group [RR 0.35 (0.17 to 0.69)]. In the home gavage group 6/45 infants developed a respiratory infection and 2/45 developed conjunctivitis; in the control group 16/43 infants developed a respiratory infection and six developed conjunctivitis. 4/45 infants in the home gavage group required antibiotics, versus 10/43 in the control group. Infection was clinically diagnosed without laboratory tests.

3.3 Death within the first 12 months post discharge
There was no significant difference in mortality between groups [RR 0.32 (0.01 to 7.62)]. One infant in the control group died of sudden infant death syndrome during the first 12 months post discharge.

Secondary outcomes

1. Satisfaction and anxiety (outcome tables 07 and 08)
Ortenstrand 1999 measured parental confidence in handling their infant by self report using Borg's category-ratio scale. A higher score indicates greater confidence. There were no significant differences in the score for confidence of either mothers [MD 0.40 (-0.66 to 1.46)] or fathers [MD 0.60 (-0.45 to 1.65)] in handling the baby at time of discharge from the home gavage program (experimental) or the corresponding time point, discharge from hospital (control).

The authors also measured parental feelings of preparedness to take responsibility for the care of their infant by self report using Borg's category-ratio scale. A higher score indicates greater preparedness. Mothers on discharge from the home gavage program scored higher in feeling prepared to take responsibility for the care of their baby compared with the control group, but this did not quite reach the conventional definition of statistical significance [MD 0.90 (-0.01 to 1.81)]. There were no significant differences in the scores of fathers between groups [MD 0.30 (-0.73 to 1.33)].

Parental anxiety was assessed using the State-Trait Inventory instrument. State anxiety is reported here because it refers to situational anxiety; a higher score indicates greater anxiety. There were no significant differences in maternal [MD -2.30 (-5.49 to 0.89)] or paternal [MD -1.80 (-4.60 to 1.00)] state anxiety scores at discharge from the home gavage program (experimental) compared with discharge from traditional hospital care (control).

2. Cost
Cost comparisons between groups were not undertaken in the included study (Ortenstrand 1999).

3. Health Service Use (outcome table 09)
Data on health service use post discharge from the home gavage program or from hospital were reported only for those who completed the one year follow up (experimental group n=41, control group n=41). There were no significant differences in the year post-discharge from home gavage program (experimental) or hospital (control) in the proportion of infants with one or more non-elective visits to general practitioners [RR 1.12 (0.68 to 1.83)], visits to paediatric outpatient clinics [RR 1.00 (0.58 to 1.72)] or visits to an emergency department [RR 0.88 (0.62 to 1.26)].

Planned sub-group analyses
Planned sub-group analyses according to type of post-discharge support received or maturity of the infant could not be undertaken because the required data were not available.

Discussion

Evidence from this single included study shows that early discharge with home support of gavage feeding for stable preterm infants resulted in a reduction in length of hospital stay and a decrease in the proportion of infants with clinically diagnosed infection. The home gavage program was not associated with any significant effect on the duration or extent of breast feeding, weight gain, parental confidence and anxiety, or health service use.

The included study made no cost comparisons from trial entry to discharge from home support versus traditional hospital care, but did document the amount of support provided during the home gavage period. This was as follows:

On face value it would appear that the costs to support an early discharge program with home support for gavage feeding would be less than in-patient hospital care but further work is necessary to adequately document and compare health care costs.

Although the single included study suggests that early discharge with home support of gavage feeding for stable preterm infants was a safe, manageable option for infant and family, and may even be beneficial, these results need to be interpreted with caution. The single trial in the review included a relatively small number of infants and was not adequately randomised. This may have resulted in a selection bias that makes it difficult to assess the true benefits and risks associated with the early discharge program. Nevertheless, the positive findings warrant further examination in high quality clinical trials with concealed allocation and adequate sample size.

Reviewers' conclusions

Implications for practice

Experimental evidence to evaluate the benefits and risks of early discharge with home gavage feeding of preterm infants compared with traditional hospital care is limited to the results of one small quasi-randomised controlled trial. Therefore recommendations for practice cannot confidently be made.

Implications for research

There is a need for trials with concealed random allocation, complete follow-up of all randomised infants, and adequate sample size to evaluate infection rates, feeding and growth, health care costs, impact on family, complications of gavage feeding, and long term developmental outcomes of preterm infants allocated to early discharge with home gavage feeding compared with traditional hospital care.

Acknowledgements

The reviewers would like to thank Ms Annica Örtenstrand (Ortenstrand 1999) for her generous contribution of unpublished data. The reviewers would also like to thank Professor Robert Dillard (Dillard 1973), Professor David P Davies (Davies 1979) and Dr Carmen Pallás (Puerto 1993) for confirmation of their study inclusion criteria.

The reviewers would like to thank Angela Falkenburg for reviewing the protocol from a parent's perspective; Karen Best for reviewing the protocol from a primary nurse perspective; Philippa Middleton (Cochrane Pregnancy and Childbirth Australian Reviewers' Group), David Henderson-Smart (Australasian regional coordinator for the Cochrane Neonatal Review Group) and Jane Bell (Research Officer, Australasian Coordinating Network for Neonatal Review Group) for assistance with this review.

Potential conflict of interest

None known

Characteristics of included studies

Study Methods Participants Interventions Outcomes Notes Allocation concealment
Ortenstrand 1999 Type of trial - quasi randomised; blinding of randomisation - no (assigned on bed availability); blinding of treatment - no (not possible for participants or providers); complete follow up - 7% attrition for primary outcomes and 14% for secondary; blinding of outcome assessment - yes. Single centre, Sweden; physiologically stable infants <37 weeks at birth with anticipated need for special care for at least another week; no apnoeic episodes or apnoea medications; normal body temperature while in open cot; parents of oxygen dependent infants able to handle equipment and monitoring; parents assessed as capable of caring for infants; read, write and understand Swedish. Excluded: triplets, quadruplets. Of 225 infants, 130 not eligible, 95 enrolled (48 infants - experimental, 47 infants - control), 7 infants/6 families withdrew from the study; 88 infants (75 families) analysed (45 infants/40 families - experimental, 43 infants/35 families - control), one year follow up 82 infants/70 families analysed (41 infants/37 families - experimental, 41 infant/33 families - control); EDG: 1 family could not be traced, 2 refused to participate; CG: SIDS x 1, one family refused to participate. Intention to treat analysis undertaken.
Experimental group: early discharge with domiciliary care home visits, gavage feeding at home by parents for 80% (36/45), continued on program until infants met control group criteria for discharge home as assessed by neonatologist. Domiciliary visits provided by experienced registered nurse, available Monday to Friday 8 am to 5 pm for scheduled and unscheduled home visits, available Monday to Friday out of hours by mobile phone, no home visits on weekends, parents could phone neonatal ward for help. Control group: Discharged home when clinically well, on full bottle &/or breast feeds and gaining weight satisfactorily. Breast feeding (exclusive and any) on discharge from domiciliary care or hospital, duration of breast feeding to 12 months after discharge; weight gain during period of domiciliary care; length of hospitalisation, rehospitalisation during period of domiciliary care; rehospitalisation during first year (from end of domiciliary care period or discharge form hospital); infection during period of domiciliary care; death within first year; health service use during first year post discharge; anxiety and confidence in handling baby.
C

Characteristics of excluded studies

Study Reason for exclusion
Bhargava 1980 Inclusion criterion full sucking feeds
Brooten 1986 Inclusion criterion full sucking feeds
Casiro 1993 Inclusion criterion full sucking feeds
Charpak 1997 Inclusion criterion full sucking feeds
Cruz 1997 Inclusion criterion full sucking feeds
Davies 1979 Inclusion criterion full sucking feeds
Dillard 1973 Inclusion criterion full sucking feeds
Finello 1998 Inclusion criterion full sucking feeds
Lefebvre 1982 Inclusion criterion full sucking feeds
Puerto 1993 Inclusion criterion full sucking feeds

References to studies

References to included studies

Ortenstrand 1999 {published and unpublished data}

* Örtenstrand A, Waldenström U, Winbladh B. Early discharge of preterm infants needing limited special care, followed by domiciliary nursing care. Acta Paediatrica 1999;88:1024-30.

Örtenstrand A, Winbladh B, Nordström G, Waldenström U. Early discharge of preterm infants followed by domiciliary nursing care: parents' anxiety, assessment of infant health and breastfeeding. Acta Paediatrica 2001;90:1190-95.

References to excluded studies

Bhargava 1980 {published data only}

Bhargava SK, Kumari S, Bawa S, Choudhury P, Lall UB. Early discharge of infants with weight of 1800 g. or less. Indian Pediatrics 1980;17:425-429.

Brooten 1986 {published data only}

Brooten D, Kumar S, Brown LP, Butts P, Finkler SA, Bakewell-Sachs S, Giggons A, Delivoria-Papadopoulos M. A randomized clinical trial of early hospital discharge and home follow-up of very-low-birth-weight infants. New England Journal of Medicine 1986;315:934-9.

Casiro 1993 {published data only}

Casiro OG, McKenzie ME, McFayden L, Shapiro C, Seshia MM, MacDonald N, Moffatt M, Cheang MS. Earlier discharge with community-based intervention for low birth weight infants: A randomized trial. Pediatrics 1993;92:128-34.

Charpak 1997 {published data only}

Charpak N, Ruiz-Peláez JG, Figueroa de C Z, Charpak Y. Kangaroo mother versus traditional care for newborn infants <=2000 grams: A randomized, controlled trial. Pediatrics 1997;100:682-688.

Cruz 1997 {published data only}

Cruz H, Guzman N, Rosales M, Bastidas J, Garcia J, Hurtado I, Rojas ME, Hodgman JE. Early hospital discharge of preterm very low birth weight infants. Journal of Perinatology 1997;17:29-32.

Davies 1979 {published and unpublished data}

Davies DP, Haxby V, Herbert S, McNeish AS. When should pre-term babies be sent home from neonatal units? The Lancet 1979;1:914-915.

Dillard 1973 {published and unpublished data}

Dillard RG, Korones SB. Lower discharge weight and shortened nursery stay for low-birth-weight infants. The New England Journal of Medicine 1973;288:131-33.

Finello 1998 {published data only}

Finello KM, Litton KM, deLemos R, Chan LS. Very low birth weight infants and their families during the first year of life: Comparisons of medical outcomes based on after care services. Journal of Perinatology 1998;18:365-71.

Lefebvre 1982 {published data only}

Lefebvre F, Veilleux A, Bard H. Early discharge of low birthweight infants. Archives of Disease in Childhood 1982;57:511-13.

Puerto 1993 {published and unpublished data}

Martin Peurto MJ, Gomez Castillo E, Pascual Patrao M, Pallas Alonso C. Alta precoz en recien nacidos de bajo peso. Experiencia de 5 anos [Early discharge of low-birth-weight neonates. 5-year experience]. Anales Espanoles de Pediatria 1993;38:20-4.

References to studies awaiting assessment

Gibson 1998 {published data only}

Gibson E, Medoff-Cooper B, Nuamah IF, Gerdes J, Kirkby S, Greenspan J, The Early Discharge Study Group. Accelerated discharge of low birth weight infants from neonatal intensive care: A randomized, controlled trial. Journal of Perinatology 1998;19:S17-S23.

* indicates the primary reference for the study

Other references

Additional references

AAP 1998

American Academy of Pediatrics. Hospital discharge of the high-risk neonate - proposed guidelines. Pediatrics 1998;102:411-17.

Clarke 2003

Clarke M, Oxman AD, editors. Cochrane Reviewer's Handbook 4.1.6 [updated January 2003]. In:The Cochrane Library, Issue 1, 2003. Oxford: Update Software. Updated quarterly, 2003.

Evanochko 1996

Evanochko C, Jancs-Kelley S, Boyle R, Fox M, Molesky M, Byrne P. Facilitating early discharge from the NICU: the development of a home gavage program and neonatal outpatient clinic. Neonatal Network 1996;15:44.

Evans 1988

Evans ID. Tubefeeding newborn babies at home. Journal of the Royal Army Medical Corps 1988;134:149-50.

Gibson 1996

Gibson E, Medoff-Cooper B, Kirkby S, Stavis R, Gerdes JS, Thompson JM, Greenspan JS. Early discharge of premature infants: a randomized controlled study. Pediatric Research 1996;39(4):Abstract 1242, p210A.

Labbok 1990

Labbok M, Krasovek K. Toward consistency in breastfeeding definitions. Studies in Family Planning 1990;21:226-30.

Laddem 1992

Laddem M, Damato E. Parenting and supportive programs. NAACOG's Clinical Issues in Perinatal and Women's Health Nursing 1992;3:174-87.

Swanson 1997

Swanson SC, Naber MM. Neonatal integrated home care: nursing without walls. Neonatal Network 1997;16:33-8.

Wakefield 1994

Wakefield J, Ford L. Nasogastric tube feeding and early discharge. Paediatric Nursing 1994;6:18-19.

Comparisons and data

01 Early discharge to home gavage program versus later discharge on full sucking feeds

01.01 Stopped any breast feeding by different times (proportion of infants)

01.02 Stopped fully breast feeding at different times (proportion of infants)

01.03 Weight gain (g/day) on discharge from home gavage program (exp) or discharge from hospital (control)

01.04 Length of hospitalisation

01.05 Infants with one or more hospital re-admissions

01.06 Infants with one or more adverse events

01.07 Parental satisfaction on discharge from home gavage program (exp) or discharge from hospital (control)

01.08 Parental anxiety on discharge from home gavage program (exp) or discharge from hospital (control)

01.09 Health service use post discharge from home gavage program (exp) or from hospital (control)


Comparison or outcome Studies Participants Statistical method Effect size
01 Early discharge to home gavage program versus later discharge on full sucking feeds
01 Stopped any breast feeding by different times (proportion of infants)     RR (fixed), 95% CI Subtotals only
02 Stopped fully breast feeding at different times (proportion of infants)     RR (fixed), 95% CI Subtotals only
03 Weight gain (g/day) on discharge from home gavage program (exp) or discharge from hospital (control) 1 88 WMD (fixed), 95% CI -1.10 [-3.94, 1.74]
04 Length of hospitalisation 1 88 WMD (fixed), 95% CI -9.30 [-18.49, -0.11]
05 Infants with one or more hospital re-admissions     RR (fixed), 95% CI Subtotals only
06 Infants with one or more adverse events     RR (fixed), 95% CI Subtotals only
07 Parental satisfaction on discharge from home gavage program (exp) or discharge from hospital (control)     WMD (fixed), 95% CI Subtotals only
08 Parental anxiety on discharge from home gavage program (exp) or discharge from hospital (control)     WMD (fixed), 95% CI Subtotals only
09 Health service use post discharge from home gavage program (exp) or from hospital (control)     RR (fixed), 95% CI Subtotals only

Notes

Published notes

Amended sections

Cover sheet
Synopsis
Abstract
Background
Objectives
Criteria for considering studies for this review
Search strategy for identification of studies
Methods of the review
Description of studies
Methodological quality of included studies
Results
Discussion
Reviewers' conclusions
Acknowledgements
References to studies
Other references
Characteristics of included studies
Characteristics of excluded studies
Characteristics of ongoing studies
Comparisons, data or analyses

Contact details for co-reviewers

Dr Maria Makrides
Head, Applied Nutrition Group
Child Health Research Institute
Women's & Children's Hospital
72 King William Road
North Adelaide
SA AUSTRALIA
5006
Telephone 1: +61 8 8161 6067
Telephone 2: +61 8 8161 6179
Facsimile: +61 8 8161 7481
E-mail: makridesm@mail.wch.sa.gov.au

Dr Andrew J McPhee
Deputy Head
Neonatal Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia AUSTRALIA
5006
Telephone 1: 61 8 8161 7631
E-mail: mcpheea@wch.sa.gov.au



This review is published as a Cochrane review in The Cochrane Library 2004, Issue 1, 2004 (see www.CochraneLibrary.net for information). Cochrane reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and The Cochrane Library should be consulted for the most recent version of the Review.