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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03292562

Enrollment

Registered

2017-09-25

Start date

2017-09-19

Completion date

2019-03-31

Last updated

2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Prematurity, Respiratory Distress Syndrome

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.

Interventions

DEVICEDiscontinue 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).

DEVICEDiscontinue 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Days on NCPAP or Mechanical Ventilation	from 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

Measure	Time frame	Description
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)	—
Duration of Endotracheal Ventilation	from 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 Stay	from admission to hospital until discharge (about 92 days)	—
Number of Participants Who Developed Air Leak Disorders	from randomization until discharge (about 92 days)	Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth	from randomization until discharge (about 92 days)	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Discontinue NCPAP After Weaning Pressures After randomization, CPAP pressure will be weaned by 1 every 24 hrs 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 (described below) 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 1L flow, 30% FiO2). 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 (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.	35
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 1L 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 1L flow, 30% FiO2).	31
Total	66

Baseline characteristics

Characteristic	Discontinue NCPAP Without Weaning Pressures	Total	Discontinue NCPAP After Weaning Pressures
Age, Continuous	31.1 weeks	31.3 weeks	31.4 weeks
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	31 Participants	66 Participants	35 Participants
Sex: Female, Male Female	19 Participants	39 Participants	20 Participants
Sex: Female, Male Male	12 Participants	27 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 31
other Total, other adverse events	0 / 35	0 / 31
serious Total, serious adverse events	0 / 35	0 / 31

Outcome results

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.

Time frame: from randomization until 28 days post-randomization

Arm	Measure	Value (MEAN)
Discontinue NCPAP After Weaning Pressures	Number of Days on NCPAP or Mechanical Ventilation	17.3 days
Discontinue NCPAP Without Weaning Pressures	Number of Days on NCPAP or Mechanical Ventilation	12.3 days

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.

Time frame: from randomization until 28 days post-randomization

Population: Data for this measure was not collected.

Secondary

Length of Hospital Stay

Time frame: from admission to hospital until discharge (about 92 days)

Arm	Measure	Value (MEAN)
Discontinue NCPAP After Weaning Pressures	Length of Hospital Stay	91.2 days
Discontinue NCPAP Without Weaning Pressures	Length of Hospital Stay	93.3 days

Secondary