Status:
COMPLETED
NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
Lead Sponsor:
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborating Sponsors:
Vittore Buzzi Children's Hospital
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Conditions:
RDS of Prematurity
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respirat...
Detailed Description
A Randomized Control Trial (RCT) conducted in two tertiary level Neonatal Intensive Care Unit (NICU). Ethical approval is needed. Informed and written consent will be obtained prior the delivery from ...
Eligibility Criteria
Inclusion
- All inborn VLBW infants (birthweight less than 1500 g and Gestational Age \< 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.
Exclusion
- Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
- Newborns with genetic disease and/or with major congenital malformations
- Newborns for whom it was not obtained informed consent within two hours from birth
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT02259400
Start Date
January 1 2010
End Date
December 1 2012
Last Update
February 18 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.