Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00244101 |
Other study ID # |
CHRMS 03-233 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
August 2003 |
Est. completion date |
June 2011 |
Study information
Verified date |
November 2022 |
Source |
Vermont Oxford Network |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.