Early Hospital Discharge Program in Neonatology (EDNEO)
Primary Purpose
Prematurity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Early Discharge
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity focused on measuring Parental stress, Early discharge, Anxiety, Depression, Neonatal Intensive Care Unit
Eligibility 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
Sites / Locations
- Hospital Universitario La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EDA
SDP
Arm Description
Neonates submitted to the protocol of early discharge.
Discharge following the standard protocol of the neonatal intensive care unit.
Outcomes
Primary Outcome Measures
Reduction in the length of hospitalization.
Secondary Outcome Measures
Parental stress
Use of Health Resources of the Community
Reduction in cost of hospitalization
Full Information
NCT ID
NCT00569608
First Posted
December 6, 2007
Last Updated
December 6, 2007
Sponsor
Fundacion Para La Investigacion Hospital La Fe
1. Study Identification
Unique Protocol Identification Number
NCT00569608
Brief Title
Early Hospital Discharge Program in Neonatology
Acronym
EDNEO
Official Title
Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fundacion Para La Investigacion Hospital La Fe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Parental stress, Early discharge, Anxiety, Depression, Neonatal Intensive Care Unit
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDA
Arm Type
Experimental
Arm Description
Neonates submitted to the protocol of early discharge.
Arm Title
SDP
Arm Type
No Intervention
Arm Description
Discharge following the standard protocol of the neonatal intensive care unit.
Intervention Type
Other
Intervention Name(s)
Early Discharge
Intervention Description
Application of an early discharge protocol from the neonatal intensive care unit.
Primary Outcome Measure Information:
Title
Reduction in the length of hospitalization.
Time Frame
Days of hospitalization
Secondary Outcome Measure Information:
Title
Parental stress
Time Frame
up to 3 months post discharge
Title
Use of Health Resources of the Community
Time Frame
up to 3 months post discharge
Title
Reduction in cost of hospitalization
Time Frame
Reduction in euros/baby
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PILAR SAENZ, MD
Organizational Affiliation
AGENCIA VALENCIANA DE SALUT
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Citation
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
Results Reference
result
Citation
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
Results Reference
result
PubMed Identifier
18635681
Citation
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.
Results Reference
derived
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Early Hospital Discharge Program in Neonatology
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