Early Hospital Discharge Program in Neonatology (EDNEO)

Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Prematurity
• Intervention / Treatment: Other: Early Discharge

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46009
    • Hospital Universitario La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the length of hospitalization.	Days of hospitalization

Secondary Outcome Measures

Outcome Measure	Time Frame
Parental stress	up to 3 months post discharge
Use of Health Resources of the Community	up to 3 months post discharge
Reduction in cost of hospitalization	Reduction in euros/baby

Collaborators and Investigators

• Sponsor: Fundacion Para La Investigacion Hospital La Fe
• Investigators: Study Director: PILAR SAENZ, MD, AGENCIA VALENCIANA DE SALUT

Publications and helpful links

General Publications

• 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 Infantil La Fe, Valencia, Spain and 2Departamento de Personalidad, Evaluación y Tratamientos Psicológicos., Facultad de Psicología., Valencia, Spain. EPAS 2007; 616280.26
• 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 Universitario Materno Infantil La Fe, Valencia, Valencia, Spain and 2Dpto Personalidad, Evaluación y Tratamientos Psicológicos, Faculty of Psychology (University of Valencia), Valencia, Valencia, Spain. EPAS 2007; 616280.27
• 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 Universitario Materno Infantil La Fe, Valencia, Valencia, Spain and 2Departamento de Personalidad, Evaluación y Tratamientos Psicológicos., Facultad de Psicología.Universidad de Valencia., Valencia, Valencia, Spain. EPAS 2007; 618442.13
• Saenz P, Cerda M, Diaz 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. doi: 10.1136/adc.2007.135921. Epub 2008 Jul 17.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: December 6, 2007
• First Submitted That Met QC Criteria: December 6, 2007
• First Posted (Estimate): December 7, 2007

Study Record Updates

• Last Update Posted (Estimate): December 7, 2007
• Last Update Submitted That Met QC Criteria: December 6, 2007
• Last Verified: June 1, 2005

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Early discharge; Parental stress; Neonatal Intensive Care Unit
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: FIHLaFe; AP015/06