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

Completed · Phase 3

Conditions studied: Respiratory Distress Syndrome, Newborn

In brief

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.

Key facts

Study ID

NCT00244101

Run by

Vermont Oxford Network

People needed

648

Starts

2003-08-01

Expected to finish

2011-06-01

Last updated by the study team

2023-01-18

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Vermont Oxford Network — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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