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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292562
• Other study ID #: HSC-MS-17-0334
• Status: Completed
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 31, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea of Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants Who Failed to Wean Off NCPAP		from randomization until discharge (about 92 days)
Secondary	Number of Participants Who Developed Bronchopulmonary Dysplasia		from randomization until discharge (about 92 days)
Secondary	Number of Participants Who Developed Necrotizing Enterocolitis		from randomization until discharge (about 92 days)
Secondary	Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth		from randomization until discharge (about 92 days)
Secondary	Length of Hospital Stay		from admission to hospital until discharge (about 92 days)
Secondary	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)