Status:
COMPLETED
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Lead Sponsor:
Vermont Oxford Network
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
26-29 years
Phase:
PHASE3
Brief Summary
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delive...
Detailed Description
The "Delivery room management of premature infants at high risk of respiratory distress syndrome" protocol compares three distinct methods of post-delivery stabilization and subsequent early respirato...
Eligibility Criteria
Inclusion
- Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:
- Imminent delivery
- No potentially life-threatening congenital anomaly or genetic syndrome
- No known lung maturity
- Antenatal steroid status known
- Written, informed consent obtained (on admission or prior to delivery).
Exclusion
- Stillborn (Apgar score of 0 at one minute of age)
- Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT00244101
Start Date
August 1 2003
End Date
June 1 2011
Last Update
January 18 2023
Active Locations (1)
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1
Vermont Oxford Network
Burlington, Vermont, United States, 05401