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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Apnea of Prematurity
• Intervention / Treatment: Device: Discontinue NCPAP after weaning pressures; Device: Discontinue NCPAP without weaning pressures

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Discontinue NCPAP after weaning pressures; 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; 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).
Active Comparator: Discontinue NCPAP without weaning pressures; 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; 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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Brittany Duyka, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: February 29, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: HSC-MS-17-0334

Drug and device information, study documents

• 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