Early Hospital Discharge Program in Neonatology

Prematurity Clinical Trial

— EDNEO  

Official title:

Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569608
• Other study ID #: FIHLaFe
• Secondary ID: AP015/06
• Status: Completed
• Phase: N/A
• First received: December 6, 2007
• Last updated: December 6, 2007
• Start date: January 2005
• Est. completion date: October 2006

Study information

• Verified date: June 2005
• Source: Fundacion Para La Investigacion Hospital La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Weeks to 42 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• Early Discharge
Application of an early discharge protocol from the neonatal intensive care unit.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Para La Investigacion Hospital La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Psychological distress in parents of premature infants at discharge from the nicu. Saénz P1, Cerdá M1, Gorba M1, Díaz Cordobés JL2, Yi, P2, Barreto, P2 ;Vento M (Sponsored by Maximo V, Prof)1Servicio de Neonatología, Hospital Universitario Materno Infanti

Psychological follow up of parents of preterm infants enrolled in an early discharge program from the nicu. Saénz P1, Díaz Cordobés JL2, Cerdá M1, Boronat N1, Barreto P2, Yi P2; Vento M1. (Sponsored by Maximo Vento,)1Servicio de Neonatología, Hospital Uni

Vulnerability Of Parents Of Very Low Birth Weight Infants (Vlbw) During Nicu Hospitalization. Saénz P1, Díaz Cordobés JL2, Cerdá M1, Boronat N1, Yi P2, Barreto P2 ; Vento M1. (Sponsored by Maximo Vento, Prof)1 Servicio de Neonatología, Hospital Universita

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the length of hospitalization.		Days of hospitalization	Yes
Secondary	Parental stress		up to 3 months post discharge	No
Secondary	Use of Health Resources of the Community		up to 3 months post discharge	No
Secondary	Reduction in cost of hospitalization		Reduction in euros/baby	No