Status:
TERMINATED
Pilot Study to Assess Safety and Feasibility of Resuscitation of Preterm Infants With Controlled Volume of Air/Oxygen
Lead Sponsor:
Mount Sinai Hospital, Canada
Conditions:
Resuscitation
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
Brief Summary
QUESTION: Is controlled tidal volume delivery during the resuscitation of preterm infants \< 28 weeks' gestation safe and feasible? BACKGROUND AND RATIONALE: Current resuscitation of preterm neonate...
Detailed Description
Design Randomized controlled pilot study. Setting: The study will be conducted at the Mount Sinai Hospital (MSH), Toronto which is a tertiary care teaching hospital in the Greater Toronto Area. Appro...
Eligibility Criteria
Inclusion
- All neonates born at \<28 completed weeks' gestation according to early ultrasonographic estimation or maternal account of last menstrual period.
Exclusion
- Antenatally diagnosed congenital cardio-respiratory anomalies
- Infants with known chromosomal or genetic abnormalities
- A prior knowledge of significant fetal distress (diagnosed on the basis of cardiographic monitoring and defined as fetal heart rate \<100 beats per minute and/or loss of beat to beat variability, and/or biophysical profile of \<4/8)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00157989
Start Date
October 1 2004
End Date
August 1 2006
Last Update
September 11 2006
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5