NCT00569608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
Last Updated

December 7, 2007

Status Verified

June 1, 2005

First QC Date

December 6, 2007

Last Update Submit

December 6, 2007

Conditions

Prematurity

Keywords

Parental stressEarly dischargeAnxietyDepressionNeonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Reduction in the length of hospitalization.

    Days of hospitalization

Secondary Outcomes (3)

  • 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

Study Arms (2)

EDA

EXPERIMENTAL

Neonates submitted to the protocol of early discharge.

Other: Early Discharge

SDP

NO INTERVENTION

Discharge following the standard protocol of the neonatal intensive care unit.

Interventions

Early DischargeOTHER

Application of an early discharge protocol from the neonatal intensive care unit.

EDA

Eligibility Criteria

Age36 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Active disease
  • Need for hospital intervention
  • Major congenital malformations
  • Chromosomopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Related Publications (4)

  • 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

    RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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.

    PMID: 18635681DERIVED

MeSH Terms

Conditions

Premature BirthAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • PILAR SAENZ, MD

    AGENCIA VALENCIANA DE SALUT

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

January 1, 2005

Study Completion

October 1, 2006

Last Updated

December 7, 2007

Record last verified: 2005-06

Locations

ES(1)