Status:
UNKNOWN
Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Lead Sponsor:
Third Military Medical University
Conditions:
RDS
Infant, Newborn
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE3
Brief Summary
To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant.
Detailed Description
Chronic lung disease (CLD) of prematurity is the major cause of long-term disability of extremely LBW (ELBW) premature infants, and it is the most cost consumptive disease in Neonatal Intensive Care U...
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 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01265589
Start Date
January 1 2012
End Date
December 1 2013
Last Update
July 26 2011
Active Locations (1)
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1
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042