Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Early Hospital Discharge Program in Neonatology (EDNEO)

This study has been completed.
Information provided by:
Fundacion Para La Investigacion Hospital La Fe Identifier:
First received: December 6, 2007
Last updated: NA
Last verified: June 2005
History: No changes posted

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
Other: Early Discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Experimental: EDA
Neonates submitted to the protocol of early discharge.
Other: Early Discharge
Application of an early discharge protocol from the neonatal intensive care unit.
No Intervention: SDP
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.


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

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
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Please refer to this study by its identifier: NCT00569608

Hospital Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Fundacion Para La Investigacion Hospital La Fe
  More Information

No publications provided by Fundacion Para La Investigacion Hospital La Fe

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: JOSE LUIS CASTELL RIPOLL, FUNDACION INVESTIGACION HOSPITAL LA FE Identifier: NCT00569608     History of Changes
Other Study ID Numbers: FIHLaFe, AP015/06
Study First Received: December 6, 2007
Last Updated: December 6, 2007
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:
Parental stress
Early discharge
Neonatal Intensive Care Unit processed this record on February 27, 2015