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Completed

NCT Number: NCT03292562

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

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.

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Key information

Conditions

Apnea of Prematurity Apnea Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discontinue NCPAP after weaning pressures

Device

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

Device

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).

Primary outcomes

  1. Number of Days on NCPAP or Mechanical Ventilation

    Time frame: 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 outcomes

  1. Duration of Endotracheal Ventilation

    Time frame: 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.

  2. Number of Participants Who Failed to Wean Off NCPAP

    Time frame: from randomization until discharge (about 92 days)

  3. Number of Participants Who Developed Bronchopulmonary Dysplasia

    Time frame: from randomization until discharge (about 92 days)

  4. Number of Participants Who Developed Necrotizing Enterocolitis

    Time frame: from randomization until discharge (about 92 days)

  5. Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth

    Time frame: from randomization until discharge (about 92 days)

  6. Length of Hospital Stay

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

  7. Number of Participants Who Developed Air Leak Disorders

    Time frame: from randomization until discharge (about 92 days)

    Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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