Early Hospital Discharge Program in Neonatology - Full Text View

Sponsored by:	Fundacion Para La Investigacion Hospital La Fe
Information provided by:	Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:	NCT00569608

Purpose

Early discharge of premature infants from the Neonatal Intensive Care Unit will have substantial benefits:

(i) diminish parental stress;

(ii) increase parental - child bonding;

(iii) diminish medical complications derived from prolonged hospitalization;

(iv) reduce cost;

(v) increase number of point of attendance disponible for future patients.

Condition	Intervention
Prematurity	Other: Early Discharge

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit

Further study details as provided by Fundacion Para La Investigacion Hospital La Fe:

Primary Outcome Measures:

Reduction in the length of hospitalization. [ Time Frame: Days of hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Parental stress [ Time Frame: up to 3 months post discharge ] [ Designated as safety issue: No ]
Use of Health Resources of the Community [ Time Frame: up to 3 months post discharge ] [ Designated as safety issue: No ]
Reduction in cost of hospitalization [ Time Frame: Reduction in euros/baby ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	January 2005
Study Completion Date:	October 2006

Arms	Assigned Interventions
EDA: Experimental Neonates submitted to the protocol of early discharge.	Other: Early Discharge Application of an early discharge protocol from the neonatal intensive care unit.
SDP: No Intervention Discharge following the standard protocol of the neonatal intensive care unit.

Detailed Description:

Extremely premature infants have to remain for very prolonged time in the hospital. As a consequence, difficulties for establishing an adequate parental-infant bonding arise causing a substantial parental stress manifested as anxiety and depression, and increasing the risk of short and longterm consequences (neglect, abuse, maltreatment, abandonment). In addition, prolonged hospital stay will increase the probability of having medical complications (infections, excessive blood tests or image studies) and the cost of staying. Once the baby has improved sufficiently early discharge may be given independently of the baby's weight. In order to be successful, caregivers, psychologist and parents have to put forward an established protocol to be able to face satisfactorily this situation. We hypothesize that, with an adequate Early Discharge Program, we could substantially reduce length of hospitalization, cost, and reduce parental stress.

Eligibility

Ages Eligible for Study:	36 Weeks to 42 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prematurity
No need for hospital support
Parents fulfill sociological score
Cooperation of primary care pediatrician

Exclusion Criteria:

Active disease
Need for hospital intervention
Major congenital malformations
Chromosomopathies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569608

Locations

Spain
Hospital Universitario La Fe
VALENCIA, Spain, 46009

Sponsors and Collaborators

Fundacion Para La Investigacion Hospital La Fe

Investigators

Study Director:

PILAR SAENZ, MD

AGENCIA VALENCIANA DE SALUT

More Information

Responsible Party:	FUNDACION INVESTIGACION HOSPITAL LA FE ( JOSE LUIS CASTELL RIPOLL )
Study ID Numbers:	FIHLaFe, AP015/06
Study First Received:	December 6, 2007
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00569608
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:

Parental stress
Early discharge
Anxiety
Depression
Neonatal Intensive Care Unit

Study placed in the following topic categories:

Depression
Stress
Depressive Disorder

ClinicalTrials.gov processed this record on January 15, 2009