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Completed

NCT Number: NCT03298035

A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).

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Key information

Conditions

Apnea of Prematurity Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders 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, 70030, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
  • Infants on maximum caffeine therapy (10mg/kg/day)

Exclusion criteria

  • Major congenital anomalies including congenital heart disease

Treatment and study plan

NCPAP as mode for apnea prevention

Device

With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.

NIPPV as rescue mode for apnea prevention

Device

With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.

Primary outcomes

  1. Number of Participants Who Were Intubated

    Time frame: 28 days after randomization

  2. Duration of Intubation

    Time frame: 28 days after randomization

Secondary outcomes

  1. Number of Apneic Events

    Time frame: 28 days after randomization

  2. Number of Participants With Bronchopulmonary Dysplasia (BPD)

    Time frame: 36 weeks corrected gestational age

  3. Number of Participants With Necrotizing Enterocolitis (NEC)

    Time frame: 36 weeks corrected gestational age

  4. Number of Participants With Air Leak Disorders

    Time frame: 36 weeks corrected gestational age

    Air leak disorders include pneumothorax and/or pneumomediastinum.

  5. Weight Gain

    Time frame: 36 weeks corrected gestational age

  6. Length of Hospital Stay

    Time frame: about 10 to 18 weeks

  7. Number of Participants Who Died

    Time frame: until discharge (about 10 to 18 weeks) or death

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2017
Registry last updated
Feb 7, 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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