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

The University of Texas Health Science Center, Houston66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Apnea of Prematurity Respiratory Distress Syndrome

Interventions

Discontinue NCPAP after weaning pressuresDEVICE

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 pressuresDEVICE

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Number of Participants Who Failed to Wean Off NCPAP