A Phase 3 interventional study of CPAP and Mechanical ventilation in Prematurity and Respiratory Distress Syndrome, Newborn, sponsored by Children's & Women's Health Centre of British Columbia. Terminated at 6 sites in Canada. Open to participants aged 28 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2012-02-10.
Sponsored by Children's & Women's Health Centre of British Columbia · Phase 3, Interventional, and Prevention
In Canada each year, there are approximately 800 infants born between 28 and 32 weeks gestation. Up to 60% of these infants will require breathing tube placement for Respiratory Distress Syndrome or RDS. RDS is a lung disease of prematurity due to a lack of a compound called surfactant. The breathing tube is placed as a conduit for placing surfactant into the babies' lungs to improve the lung disease. Most babies are then placed on a breathing machine or ventilator. Ventilation is not without harm and can be associated with lung damage, delays in feeding, increased hospital stay and interruption of bonding. An alternative that does not require the presence of a breathing tube is Continuous Positive Airway Pressure (CPAP). We will randomize babies to either ventilation or CPAP to try to minimize the length of time the baby is kept on respiratory support.
Objectives: To determine whether infants 28 to 32 weeks gestational age with RDS treated with surfactant followed by CPAP have a shorter length of respiratory support (length of time on a ventilator and CPAP) than similar infants who are treated with MV after surfactant therapy; and to examine secondary outcomes including outcomes related to lung disease, feeding issues and hospital length of stay (secondary outcomes).
Hypothesis: The use of CPAP after surfactant in infants born 28 to 32 weeks with RDS will reduce the length of respiratory support as compared with infants treated with MV. We hypothesize that the incidence of lung disease and feeding issues will be similar between groups while length of hospital stay will be shorter in the CPAP group.
Methods: A multi-center, randomized trial conducted in seven neonatal intensive care units in Canada and France. Parents will be approached for consent prior to delivery or after the infant shows signs of RDS. Infants 28 to 32 weeks gestation with RDS will be eligible for the study. After intubation and surfactant administration, babies will be randomized to either receive CPAP or MV. Strict criteria for CPAP failure, weaning ventilation and weaning and discontinuing CPAP will be specified. Infants will be followed in the nursery until hospital discharge or until all outcomes have been determined.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 126 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Children's & Women's Health Centre of British Columbia is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Mechanical ventilation
Device: Mechanical ventilation
CPAP
Device: CPAP
CPAP administered via "Bubble" method or Infant Flow Driver
Volume guarantee strategy
Length of respiratory support
CPAP plus MV days
Time frame: Variable
Duration of ventilation, duration of oxygen therapy, pneumothorax rate and BPD by Walsh test, time to full feeds, time to regain birthweight, necrotizing enterocolitis, time to discharge, achievement of readiness for discharge criteria
Time frame: Variable
This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Children's & Women's Health Centre of British Columbia