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A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

Not Applicable
Completed
Conditions
Apnea of Prematurity
Respiratory Distress Syndrome
Interventions
Device: Discontinue NCPAP after weaning pressures
Device: Discontinue NCPAP without weaning pressures
Registration Number
NCT03292562
Lead Sponsor
The University of Texas Health Science Center, Houston
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Discontinue NCPAP after weaning pressuresDiscontinue NCPAP after weaning pressuresAfter 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).
Discontinue NCPAP without weaning pressuresDiscontinue NCPAP without weaning pressuresAfter 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 Measures
NameTimeMethod
Number of Days on NCPAP or Mechanical Ventilationfrom randomization until 28 days post-randomization

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
NameTimeMethod
Number of Participants Who Failed to Wean Off NCPAPfrom randomization until discharge (about 92 days)
Duration of Endotracheal Ventilationfrom randomization until 28 days post-randomization

Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.

Length of Hospital Stayfrom admission to hospital until discharge (about 92 days)
Number of Participants Who Developed Necrotizing Enterocolitisfrom randomization until discharge (about 92 days)
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouthfrom randomization until discharge (about 92 days)
Number of Participants Who Developed Bronchopulmonary Dysplasiafrom randomization until discharge (about 92 days)
Number of Participants Who Developed Air Leak Disordersfrom randomization until discharge (about 92 days)

Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

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