Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 3

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:

        1. Intubation, prophylactic surfactant administration shortly after delivery, and
           subsequent stabilization on ventilator support.

        2. Early stabilization on nasal continuous positive airway pressure (NCPAP) with selective
           intubation and surfactant administration for clinical indications.

        3. 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:

        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 and informed consent obtained prior to delivery.

      Exclusion criteria will include:

        1. stillborn infants (Apgar score of 0 at one minute of age) or

        2. infants noted to have a potentially life-threatening congenital anomaly or genetic
           syndrome noted immediately after delivery.

      Eligible infants will have consent obtained prior to delivery. They will be stratified into
      two groups: 26 + 0 to 27 + 6 weeks gestation and 28 + 0 to 29 + 6 weeks gestation. Shortly
      before delivery, infants will be randomized to one of the three stabilization strategies
      detailed below:

        1. Intubation, prophylactic surfactant administration shortly after delivery, and
           subsequent stabilization on ventilator support (PS group).

        2. Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected
           intubation and surfactant administration for clinical indications (NCPAP group).

        3. Intubation, prophylactic surfactant administration shortly after delivery, and rapid
           extubation to nasal CPAP (ISX group).

      Infants requiring intubation for respiratory failure during this study (in any of the three
      groups) may be stabilized on either conventional or high-frequency ventilation. Specific
      criteria regarding target ranges for blood gases and indications for extubation, subsequent
      surfactant dosing, management of extubation, and criteria for reintubation, are all detailed
      in the protocol.

      The primary outcome measure is chronic lung disease (defined as documented requirement for
      supplemental oxygen or respiratory support) or mortality at 36 weeks adjusted age. Secondary
      outcome measures include a variety of clinical outcomes, as well as issues regarding duration
      of hospital stay and other resource utilization. Long-term outcomes will be measured by a
      health care questionnaire at two years of age. A sample size of over 895 infants will be
      required to demonstrate a 25% reduction in the risk of chronic lung disease at 36 weeks
      adjusted age.
    

Intervention name(s): PS Group; NCPAP Group; ISX Group
Intervention type(s): Drug; Device; Drug
Intervention description(s): Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.; Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.; Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Other intervention name(s): Prophylactic Surfactant Group; Nasal CPAP group; Intubation, Surfactant Administration, Extubation to Nasal CPAP. ENSURE.
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prematurity; respiratory distress syndrome; surfactant; nasal continuous positive airway pressure