Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Vermont Oxford Network
- Enrollment
- 648
- Locations
- 1
- Primary Endpoint
- Death or Chronic Lung Disease
Study Overview
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-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.
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 respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress syndrome. The three approaches to post-delivery care include:
- Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
- Early stabilization on nasal continuous positive airway pressure (NCPAP) with selective intubation and surfactant administration for clinical indications.
- Intubation, prophylactic surfactant administration shortly after delivery and rapid extubation to nasal CPAP.
The primary null hypothesis for this study is that no difference will be found in chronic lung disease and/or mortality at 36 weeks adjusted age in premature infants at high risk of RDS, depending on the method of post-delivery stabilization.
The study is a randomized, multicenter trial conducted at participating Vermont Oxford Network Centers. Participating centers will demonstrate competency in the use of nasal CPAP by successfully completing a web-based, educational program and utilizing nasal CPAP in a minimum of 20 infants in their NICU.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 26 Weeks to 29 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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 Criteria
- •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.
Arms & Interventions
PS Group
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Intervention: PS Group (Drug)
NCPAP Group
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Intervention: NCPAP Group (Device)
ISX Group
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Intervention: ISX Group (Drug)
Outcomes
Primary Outcomes
Death or Chronic Lung Disease
Time Frame: at 36 weeks postmenstrual age
Death
Time Frame: 36 weeks adjusted age
Secondary Outcomes
No secondary outcomes reported