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Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064712
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date October 22, 2018
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
Total days of NCPAP [ Time Frame: Until hospital discharge or 1 year of life ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Length of hospital stay [ Time Frame: Until hospital discharge or 1 year of life ]
  • Duration of oxygen supplementation [ Time Frame: Until hospital discharge or 1 year of life ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
Official Title  ICMJE Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
Brief Summary 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.
Detailed Description

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn
  • Infant, Premature
Intervention  ICMJE
  • Other: Low CPAP Wean
    Infants receive NCPAP by Hudson nasal prongs.
  • Other: High CPAP Wean
    Infants receive NCPAP by Hudson nasal prongs.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Low CPAP Wean
  • 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.
    Intervention: Other: High CPAP Wean
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
226
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
322
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Neonates ≤32wks GA requiring NCPAP in the delivery room or NICU for increasing respiratory distress or post-extubation from mechanical ventilation.

Exclusion Criteria:

  • Neonates requiring NCPAP for less than 48 hours
  • Congenital anomalies
  • Need for surgery
  • Transfer to a different facility
  • Grade 3-4 intraventricular hemorrhage
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 32 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064712
Other Study ID Numbers  ICMJE NCPAPwean
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Venkat Kakkilaya, MD UT Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP