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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome

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 Summary:

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. Death or Chronic Lung Disease [ Time Frame: at 36 weeks postmenstrual age ]
  2. Death [ Time Frame: 36 weeks adjusted age ]


    3. Original Primary Outcome:

    • chronic lung disease at 36 weeks adj age
    • death at 36 weeks adj age


    Current Secondary Outcome:

    • Complications of Prematurity [ Time Frame: prior to hospital discharge ]
    • Days of Ventilator Support [ Time Frame: prior to hospital discharge ]
    • Days in Hospital [ Time Frame: prior to hospital discharge ]
    • Parental Questionnaire for Health Status [ Time Frame: at 24 months of age ]


    Original Secondary Outcome: Complications of prematurity, days of ventilatory support, days in hospital, parental questionnaire for health status at 24 months of age.

    Information By: Vermont Oxford Network

    Dates:
    Date Received: October 24, 2005
    Date Started: August 2003
    Date Completion:
    Last Updated: August 16, 2012
    Last Verified: August 2012