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

The University of Texas System (UT)

Status: Completed

Conditions: Respiratory Distress Syndrome; Apnea of Prematurity

Treatments: Device: Discontinue NCPAP after weaning pressures; Device: Discontinue NCPAP without weaning pressures

Study type: Interventional

Funder types: Other

Identifiers

NCT03292562

HSC-MS-17-0334

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Discontinue NCPAP after weaning pressures

Active Comparator group

Description:

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).

Treatment:

Device: Discontinue NCPAP after weaning pressures

Discontinue NCPAP without weaning pressures

Active Comparator group

Description:

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).

Treatment:

Device: Discontinue NCPAP without weaning pressures