Safety and Feasibility of Controlled Tidal Volume Resuscitation of Preterm Infants ≤ 28 Weeks' Gestation: A Randomized Controlled Pilot Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
QUESTION:
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.
OUTCOMES:
- 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.
Detailed Description
Design Randomized controlled pilot study.
Setting: The study will be conducted at the Mount Sinai Hospital (MSH), Toronto which is a tertiary care teaching hospital in the Greater Toronto Area. Approximately 50-75 neonates <28 weeks' completed gestation are delivered at MSH per year. The institute has expertise in the resuscitation of such preterm infants. All deliveries of preterm infants are attended by an experienced respiratory therapist, a resuscitation nurse, a neonatology fellow and a pediatric resident.
Inclusion Criteria:
All neonates born at <28 completed weeks' gestation according to early ultrasonographic estimation or maternal account of last menstrual period.
Exclusion Criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Educational Counseling Training
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 1 Hour (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All neonates born at <28 completed weeks' gestation according to early ultrasonographic estimation or maternal account of last menstrual period.
Exclusion Criteria
- •Antenatally diagnosed congenital cardio-respiratory anomalies
- •Infants with known chromosomal or genetic abnormalities
- •A prior knowledge of significant fetal distress (diagnosed on the basis of cardiographic monitoring and defined as fetal heart rate <100 beats per minute and/or loss of beat to beat variability, and/or biophysical profile of <4/8)
Outcomes
Primary Outcomes
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 Outcomes
- 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