Status:
UNKNOWN
High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study
Lead Sponsor:
Bnai Zion Medical Center
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
The investigators hypothesize that while the extremely low birthweight (ELBW) infants (\<1000 g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation may enjoy th...
Eligibility Criteria
Inclusion
- Gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight \>1000 g for the initial treatment of RDS or \<35 weeks post extubation or for apnea of prematurity
- Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.
Exclusion
- Significant morbidity apart from RDS including: cardiac disease (not including patent ductus arteriosus \[PDA\]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH),
- Parents refuse consent.
- Unavailability of suitable ventilator.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01189162
Start Date
January 1 2010
End Date
July 1 2016
Last Update
August 13 2015
Active Locations (1)
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1
Bnai Zion Medical Center, Neonatal department
Haifa, Israel