Early Hospital Discharge Program in Neonatology - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 6, 2007

Last Updated Date

December 6, 2007

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Early Hospital Discharge Program in Neonatology

Official Title ^†

Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Condition ^†

Prematurity

Intervention ^†

Other: Early Discharge

Study Arms / Comparison Groups

Experimental: Neonates submitted to the protocol of early discharge.
No Intervention: Discharge following the standard protocol of the neonatal intensive care unit.

Publications *

Sáenz P, Cerdá M, Díaz JL, Yi P, Gorba M, Boronat N, Barreto P, Vento M. Psychological stress of parents of preterm infants enrolled in an early discharge programme from the neonatal intensive care unit: a prospective randomised trial. Arch Dis Child Fetal Neonatal Ed. 2009 Mar;94(2):F98-F104. Epub 2008 Jul 17.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

140

Completion Date

October 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

36 Weeks to 42 Weeks

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00569608

Responsible Party

JOSE LUIS CASTELL RIPOLL, FUNDACION INVESTIGACION HOSPITAL LA FE

Secondary IDs ^††

AP015/06

Study Sponsor ^†

Fundacion Para La Investigacion Hospital La Fe

Collaborators ^††

Investigators ^†

Study Director:

PILAR SAENZ, MD

AGENCIA VALENCIANA DE SALUT

Information Provided By

Fundacion Para La Investigacion Hospital La Fe

Verification Date

June 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.