Infant, Premature Clinical Trial
Official title:
Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
The purpose of this study is to determine an optimal strategy to wean nasal continuous positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that babies that are taken off NCPAP at lower settings will need fewer total days on NCPAP than those babies taken off at higher settings.
This is a prospective randomized control trial to investigate an optimal method for
discontinuing NCPAP therapy in preterm neonates. Neonates ≤32 weeks gestational age (GA) who
require NCPAP in the delivery room or following extubation and are delivered in or
transferred to Parkland Hospital Neonatal Intensive Care Unit (NICU) will be enrolled. The
study team will approach the parents for verbal consent once neonates are stable on
mechanical ventilation with a goal of extubation to NCPAP or once they are placed on initial
NCPAP therapy. Neonates will be randomized to the high or low NCPAP arms and managed by their
primary care team until they meet stability criteria as defined for a minimum of 12 hours. At
that time they will be removed from NCPAP using two approaches: Group 1 will be decreased to
5cm H2O by the primary care team at which time NCPAP is removed if the neonate is clinically
stable and the neonate placed in room air or on low-flow nasal cannula at ≤1L/min; Group 2
will be gradually weaned to a NCPAP of 3cm H2O at which time NCPAP is removed if the neonate
is clinically stable for the prior 24 hours and the neonate placed in room air or on low-flow
nasal cannula. Failure criteria will consist of clinical signs and laboratory results
demonstrating the need for escalation of support, e.g., increasing apnea of prematurity (AOP)
or need for increasing O2 supplementation. When a neonate has been stable for 5 days off
NCPAP, they will complete the intervention arm of the study. All neonates will be followed
until discharge, at which time the primary outcomes, e.g., days on NCPAP, duration of
hospitalization and need for O2, will be determined for each group and compared. The
calculated total sample size will require 238 neonates; i.e., 113 neonates per arm with a 5%
drop-out rate will give a power of 0.80 and alpha value of 0.05 to detect a 25% difference in
NCPAP days.
Stability Criteria:
1. NCPAP 5cm H2O
2. Supplemental oxygen <25% and not increasing
3. Respiratory rate ≤60 b/min
4. No significant respiratory distress, e.g., retractions, dyspnea
5. <3 episodes of apnea (>20 seconds) with bradycardia (<100 beats/min), and/or
desaturations (<88%) within 1h or <5 episodes in prior 12h
6. Average oxygen saturation >87% with stable inspired O2
7. Tolerate time off NCPAP during routine care procedures
8. Neonates <27 wks GA must be ≥10d postnatal before weaning
Failure Criteria:
1. Occurrence of ≥3 apneas and/or bradycardia and/or desaturations within 1h or >4 episodes
in a 12h period
2. Increasing need for supplemental O2 >30% to maintain O2 saturation >87%
3. Increase in the PaCO2 >65 mmHg
4. Increased work of breathing with respiratory rate >75 b/min for >2h
5. AOP requiring resuscitation
6. Initiation of nasal intermittent positive pressure ventilation (NIPPV) for respiratory
support
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