Back to resultsA Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
Primary Purpose
Apnea of Prematurity, Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discontinue NCPAP after weaning pressures
Discontinue NCPAP without weaning pressures
Sponsored by
About this trial
This is an interventional supportive care trial for Apnea of Prematurity
Eligibility Criteria
Inclusion Criteria:
- All infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
- Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)
Exclusion Criteria:
- Major congenital anomalies including congenital heart disease
- Anomalies that prevent discontinuation of NCPAP
- Undergoing current evaluation for and/or treatment of sepsis
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Discontinue NCPAP after weaning pressures
Discontinue NCPAP without weaning pressures
Arm Description
After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
Outcomes
Primary Outcome Measures
Number of Days on NCPAP or Mechanical Ventilation
Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Secondary Outcome Measures
Duration of Endotracheal Ventilation
Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Number of Participants Who Failed to Wean Off NCPAP
Number of Participants Who Developed Bronchopulmonary Dysplasia
Number of Participants Who Developed Necrotizing Enterocolitis
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
Length of Hospital Stay
Number of Participants Who Developed Air Leak Disorders
Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
Full Information
NCT ID
NCT03292562
First Posted
September 21, 2017
Last Updated
February 29, 2020
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03292562
Brief Title
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
Official Title
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity, Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Discontinue NCPAP after weaning pressures
Arm Type
Active Comparator
Arm Description
After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
Arm Title
Discontinue NCPAP without weaning pressures
Arm Type
Active Comparator
Arm Description
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
Intervention Type
Device
Intervention Name(s)
Discontinue NCPAP after weaning pressures
Intervention Description
After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
Intervention Type
Device
Intervention Name(s)
Discontinue NCPAP without weaning pressures
Intervention Description
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
Primary Outcome Measure Information:
Title
Number of Days on NCPAP or Mechanical Ventilation
Description
Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Time Frame
from randomization until 28 days post-randomization
Secondary Outcome Measure Information:
Title
Duration of Endotracheal Ventilation
Description
Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Time Frame
from randomization until 28 days post-randomization
Title
Number of Participants Who Failed to Wean Off NCPAP
Time Frame
from randomization until discharge (about 92 days)
Title
Number of Participants Who Developed Bronchopulmonary Dysplasia
Time Frame
from randomization until discharge (about 92 days)
Title
Number of Participants Who Developed Necrotizing Enterocolitis
Time Frame
from randomization until discharge (about 92 days)
Title
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
Time Frame
from randomization until discharge (about 92 days)
Title
Length of Hospital Stay
Time Frame
from admission to hospital until discharge (about 92 days)
Title
Number of Participants Who Developed Air Leak Disorders
Description
Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
Time Frame
from randomization until discharge (about 92 days)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)
Exclusion Criteria:
Major congenital anomalies including congenital heart disease
Anomalies that prevent discontinuation of NCPAP
Undergoing current evaluation for and/or treatment of sepsis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany Duyka, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
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