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Early Hospital Discharge Program in Neonatology

NCT ID: NCT00569608

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Prematurity

Keywords

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Parental stress Early discharge Anxiety Depression Neonatal Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EDA

Neonates submitted to the protocol of early discharge.

Group Type EXPERIMENTAL

Early Discharge

Intervention Type OTHER

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

SDP

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early Discharge

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

36 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role lead

Responsible Party

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FUNDACION INVESTIGACION HOSPITAL LA FE

Principal Investigators

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PILAR SAENZ, MD

Role: STUDY_DIRECTOR

AGENCIA VALENCIANA DE SALUT

Locations

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Hospital Universitario La Fe

Valencia, , Spain

Site Status

Countries

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Spain

References

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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

Reference Type 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

Reference Type 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

Reference Type 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.

Reference Type DERIVED
PMID: 18635681 (View on PubMed)

Other Identifiers

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AP015/06

Identifier Type: -

Identifier Source: secondary_id

FIHLaFe

Identifier Type: -

Identifier Source: org_study_id