Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
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|ClinicalTrials.gov Identifier: NCT02064712|
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infant, Newborn Infant, Premature||Other: Low CPAP Wean Other: High CPAP Wean||Not Applicable|
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.
- NCPAP 5cm H2O
- Supplemental oxygen <25% and not increasing
- Respiratory rate ≤60 b/min
- No significant respiratory distress, e.g., retractions, dyspnea
- <3 episodes of apnea (>20 seconds) with bradycardia (<100 beats/min), and/or desaturations (<88%) within 1h or <5 episodes in prior 12h
- Average oxygen saturation >87% with stable inspired O2
- Tolerate time off NCPAP during routine care procedures
- Neonates <27 wks GA must be ≥10d postnatal before weaning
- Occurrence of ≥3 apneas and/or bradycardia and/or desaturations within 1h or >4 episodes in a 12h period
- Increasing need for supplemental O2 >30% to maintain O2 saturation >87%
- Increase in the PaCO2 >65 mmHg
- Increased work of breathing with respiratory rate >75 b/min for >2h
- AOP requiring resuscitation
- Initiation of nasal intermittent positive pressure ventilation (NIPPV) for respiratory support
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||October 2018|
Active Comparator: Low CPAP Wean
NCPAP weaned to 5cm H2O for minimum of 24h, and if the neonate remains clinically stable as defined, wean in 1cm increments to 3cm H2O for minimum of 24h, at which time move to room air or 1L/min nasal cannula if supplemental O2 is required.
Other: Low CPAP Wean
Infants receive NCPAP by Hudson nasal prongs.
Active Comparator: High CPAP Wean
NCPAP weaned to 5cm H2O for a minimum of 24h, and if the neonate remains clinically stable, move to room air or 1L/min nasal cannula if supplemental O2 is required.
Other: High CPAP Wean
Infants receive NCPAP by Hudson nasal prongs.
- Total days of NCPAP [ Time Frame: Until hospital discharge or 1 year of life ]Total number of days of CPAP therapy during the hospital stay
- Length of hospital stay [ Time Frame: Until hospital discharge or 1 year of life ]Number of days spent prior to being discharged from the hospital
- Duration of oxygen supplementation [ Time Frame: Until hospital discharge or 1 year of life ]Number of days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064712
|United States, Texas|
|Parkland Memorial Hospital|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Venkat Kakkilaya, MD||UT Southwestern|