Pilot Study to Assess Safety and Feasibility of Resuscitation of Preterm Infants With Controlled Volume of Air/Oxygen
Is controlled tidal volume delivery during the resuscitation of preterm infants < 28 weeks’ gestation safe and feasible?
BACKGROUND AND RATIONALE: Current resuscitation of preterm neonates follows the Neonatal Resuscitation Program (NRP) guidelines. During initial resuscitation, neonates are bagged with self/flow inflating bags to achieve adequate chest rise, heart rate > 100 per minute and a pink color. When positive pressure ventilation is delivered with a bag, tidal volume is not measured. It is likely that high tidal volume is delivered to the neonate in order to achieve a rapid response. The evidence from human and animal model studies suggests that the initiation of mechanical ventilation and volutrauma associated with continued ventilation, are associated with an increase in pro-inflammatory mediators in the lungs of the preterm infants which induce pulmonary injury. This may interfere with the signaling involved in alveolarization, leading to a decrease in alveolar formation or maldevelopment of the alveoli, and subsequent evolution to chronic lung disease (CLD) or bronchopulmonary dysplasia (BPD).
OBJECTIVE: To evaluate the safety and feasibility of controlling tidal volume delivery (and limiting manual ventilation), during the resuscitation of preterm infants < 28 weeks’ gestation.
STUDY DESIGN AND SETTING: A randomized controlled pilot study of 40 preterm neonates at the Mount Sinai Hospital.
RESEARCH PLAN: All eligible parents at risk for preterm delivery at < 28 weeks’ gestation will be approached. After obtaining written informed consent, infants will be randomized to standard resuscitation according to NRP guidelines (control group) or resuscitation using controlled tidal volume ventilation (5 ml/kg) (study group), if they require resuscitation. Crossover to the control group will be allowed if there is clinical deterioration or no clinical improvement after 3 minutes of intervention.
- Primary: Apgar scores at 5,10, 15 and 20 minutes and pH, pO2, and pCO2 levels within 1 hour of resuscitation and at 4 hours of life.
- Secondary: Durations of mechanical ventilation, continuous positive airway pressure support, low flow oxygen/air requirement; respiratory status of infant at 28 days postnatal and 36 weeks’ corrected gestational age. Incidences of air leak, intraventricular haemorrhage and all causes of mortality before discharge from NICU will be compared.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Official Title:||Safety and Feasibility of Controlled Tidal Volume Resuscitation of Preterm Infants ≤ 28 Weeks’ Gestation: A Randomized Controlled Pilot Study|
- Apgar scores at 5,10, 15 and 20 minutes and pH, pO2, and pCO2 levels within 1 hour of resuscitation and at 4 hours of life.
- Durations of mechanical ventilation, continuous positive airway pressure support, low flow oxygen/air requirement; respiratory status of infant at 28 days postnatal and 36 weeks’ corrected gestational age
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||August 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157989
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Cecile Davey, MD||Mount Sinai Hospital, New York|