Status:
COMPLETED
Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Lead Sponsor:
Third Military Medical University
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
1-28 years
Phase:
NA
Brief Summary
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
Detailed Description
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effe...
Eligibility Criteria
Inclusion
- Newborn infants with birth weight \>500 gm.
- Gestational age \>24 completed weeks.
- Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- No known lethal congenital anomaly or genetic syndromes.
- Signed parental informed consent.
Exclusion
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00780624
Start Date
January 1 2008
End Date
December 1 2012
Last Update
April 21 2016
Active Locations (1)
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1
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042