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

NCT03298035 | Completed Results FDA Device

• 1 other identifier: HSC-MS-17-0458
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Apnea of Prematurity

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Were Intubated

  28 days after randomization

• Duration of Intubation

  28 days after randomization

Secondary Outcomes (7)

• Number of Apneic Events

  28 days after randomization

• Number of Participants With Bronchopulmonary Dysplasia (BPD)

  36 weeks corrected gestational age

• Number of Participants With Necrotizing Enterocolitis (NEC)

  36 weeks corrected gestational age

• Number of Participants With Air Leak Disorders

  36 weeks corrected gestational age

• Weight Gain

  36 weeks corrected gestational age

Study Arms (2)

NCPAP as mode for apnea prevention

ACTIVE COMPARATOR

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.

Device: NCPAP as mode for apnea prevention

NIPPV as rescue mode for apnea prevention

EXPERIMENTAL

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.

Device: NIPPV as rescue mode for apnea prevention

Interventions

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.

NCPAP as mode for apnea prevention

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.

NIPPV as rescue mode for apnea prevention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- Major congenital anomalies including congenital heart disease

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 70030, United States

Location

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pragmatic trial with inherent bias, as blinding was not possible. There was a small sample size (intent was to enroll 50, but only a few of all screened qualified for escalation of care).

Results Point of Contact

• Title: Catherine C. Beaullieu, MD
• Organization: The University of Texas Health Science Center at Houston

Catherine.C.Beaullieu@uth.tmc.edu

(713) 500-6044

Study Officials

• Claire Beaullieu, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal-Perinatal Medicine Fellow

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: November 11, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 7, 2020
• Results First Posted: February 7, 2020

Record last verified: 2020-01

Locations

US (1)