|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00569608 |
|
Date of registration:
|
06/12/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Early Hospital Discharge Program in Neonatology
EDNEO |
|
Scientific title:
|
Early Discharge Program From a Regional Reference Neonatal Intensive Care Unit |
|
Date of first enrolment:
|
January 2005 |
|
Target sample size:
|
140 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00569608 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
PILAR SAENZ, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AGENCIA VALENCIANA DE SALUT |
| | |
|
Key inclusion & exclusion 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
Age minimum:
36 Weeks
Age maximum:
42 Weeks
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Prematurity
|
|
Intervention(s)
|
|
Other: Early Discharge
|
|
Primary Outcome(s)
|
|
Reduction in the length of hospitalization.
[Time Frame: Days of hospitalization]
|
|
Secondary Outcome(s)
|
|
Parental stress
[Time Frame: up to 3 months post discharge]
|
|
Reduction in cost of hospitalization
[Time Frame: Reduction in euros/baby]
|
|
Use of Health Resources of the Community
[Time Frame: up to 3 months post discharge]
|
|
Secondary ID(s)
|
|
AP015/06
|
|
FIHLaFe
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|