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

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study

Conditions
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Apnea of Prematurity, Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Discontinue NCPAP after weaning pressures
* Device: Discontinue NCPAP without weaning pressures


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Discontinue NCPAP after weaning pressures<br>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). | Device: Discontinue NCPAP after weaning pressures<br>* 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).<br>|
| Active Comparator: Discontinue NCPAP without weaning pressures<br>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). | Device: Discontinue NCPAP without weaning pressures<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from randomization until 28 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from randomization until 28 days post-randomization | 
| Number of Participants Who Failed to Wean Off NCPAP |  | from randomization until discharge (about 92 days) | 
| Number of Participants Who Developed Bronchopulmonary Dysplasia |  | from randomization until discharge (about 92 days) | 
| Number of Participants Who Developed Necrotizing Enterocolitis |  | from randomization until discharge (about 92 days) | 
| Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth |  | from randomization until discharge (about 92 days) | 
| Length of Hospital Stay |  | from admission to hospital until discharge (about 92 days) | 
| Number of Participants Who Developed Air Leak Disorders | Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema. | from randomization until discharge (about 92 days) |