Nasal Jet-CPAP (variable flow) versus Bubble-CPAP in preterm infants with respiratory distress: an open label, randomized controlled trial.
OBJECTIVE
To compare the failure rates between Jet continuous positive airway pressure device (J-CPAP-variable flow) and Bubble continuous positive airway device (B-CPAP) in preterm infants with respiratory distress.


METHODS
Preterm newborns <34 weeks gestation with onset of respiratory distress within 6 h of life were randomized to receive J-CPAP (a variable flow device) or B-CPAP (continuous flow device). A standardized protocol was followed for titration, weaning and removal of CPAP. Pressure was monitored close to the nares in both the devices every 6 hours and settings were adjusted to provide desired CPAP. The primary outcome was CPAP failure rate within 72 h of life. Secondary outcomes were CPAP failure within 7 days of life, need for surfactant post-randomization, time to CPAP failure, duration of CPAP and complications of prematurity. An intention to treat analysis was done.


RESULTS
One-hundred seventy neonates were randomized, 80 to J-CPAP and 90 to B-CPAP. CPAP failure rates within 72 h were similar in infants who received J-CPAP and in those who received B-CPAP (29 versus 21%; relative risks 1.4 (0.8 to 2.3), P=0.25). Mean (95% confidence intervals) time to CPAP failure was 59 h (54 to 64) in the Jet CPAP group in comparison with 65 h (62 to 68) in the Bubble CPAP group (log rank P=0.19). All other secondary outcomes were similar between the two groups.


CONCLUSIONS
In preterm infants with respiratory distress starting within 6 h of life, CPAP failure rates were similar with Jet CPAP and Bubble CPAP.
Neonatal Unit, Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
A
A
Bhatti
Neonatal Unit, Fernandez Hospital, Hyderabad, India.
J
J
Khan
Neonatal Unit, Fernandez Hospital, Hyderabad, India.
S
S
Murki
Neonatal Unit, Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
V
V
Sundaram
Neonatal Unit, Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
S S
SS
Saini
Neonatal Unit, Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
P
P
Kumar
D016001:Confidence Intervals; D045422:Continuous Positive Airway Pressure / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D017052:Hospital Mortality; D006801:Humans; D007194:India; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D010100:Oxygen / Q000008:administration & dosage*; D011247:Pregnancy; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D012129:Respiratory Function Tests; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome
D010100:Oxygen