Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vermont Oxford Network
• Treatments: Pulmonary Surfactants

Criteria

Inclusion Criteria:

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:

1. Imminent delivery

2. No potentially life-threatening congenital anomaly or genetic syndrome

3. No known lung maturity

4. Antenatal steroid status known

5. Written, informed consent obtained (on admission or prior to delivery).

Exclusion Criteria:

1. Stillborn (Apgar score of 0 at one minute of age)

2. Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.