Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

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.

Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Premature Other: Low CPAP Wean Other: High CPAP Wean Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Duration of oxygen supplementation [ Time Frame: Until hospital discharge or 1 year of life ]
    Number of days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Venkat Kakkilaya, MD UT Southwestern

Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02064712    
Other Study ID Numbers: NCPAPwean
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Keywords provided by University of Texas Southwestern Medical Center:
Continuous Positive Airway Pressure