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Early Hospital Discharge Program in Neonatology (EDNEO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569608
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
  Purpose

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
Prematurity Other: Early Discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • Parental stress [ Time Frame: up to 3 months post discharge ]
  • Use of Health Resources of the Community [ Time Frame: up to 3 months post discharge ]
  • Reduction in cost of hospitalization [ Time Frame: Reduction in euros/baby ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569608


Locations
Spain
Hospital Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Fundacion Para La Investigacion Hospital La Fe
Investigators
Study Director: PILAR SAENZ, MD AGENCIA VALENCIANA DE SALUT
  More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JOSE LUIS CASTELL RIPOLL, FUNDACION INVESTIGACION HOSPITAL LA FE
ClinicalTrials.gov Identifier: NCT00569608     History of Changes
Other Study ID Numbers: FIHLaFe
AP015/06
First Submitted: December 6, 2007
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
Last Verified: June 2005

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:
Parental stress
Early discharge
Anxiety
Depression
Neonatal Intensive Care Unit


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