Non-invasive Respiratory Support in Preterm Infants

NCT03512158 | Unknown DMC

• 1 other identifier: 2018-2113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Lungs of babies born early are not fully developed and they often need a machine to help them breathe. The traditional approach to provide this support is with a breathing tube passed into the windpipe. However, we know that breathing tubes can cause injury to the fragile lungs of premature babies. Providing breathing support through nose-masks instead of breathing tubes (called nasal breathing support) is becoming popular, as it is gentler on developing lungs. Doctors, in trying to limit the use of support with a breathing tube, are using many different forms of nasal breathing support. The most common form is nasal continuous positive airway pressure (CPAP) which delivers a constant pressure and the baby breathes on his on her own. However, when this strategy is no longer able to support a premature baby's breathing, the best way to provide breathing support is not known. Some doctors use a strategy called "nasal intermittent positive airway pressure" (NIPPV) which gives the baby artificial breaths through the nose-mask. Others simply increase the pressure on nasal CPAP to higher than traditional levels. In the first study of its kind, we will compare these two strategies of nasal breathing support given to premature babies.

Conditions

Preterm Infant; Respiratory Insufficiency Syndrome of Newborn; Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (4)

• Ability to enroll a minimum of 10% of all eligible neonates per year at each site

  Ability to enroll a minimum of 30% of all admitted neonates \< 29 weeks GA who do not meet exclusion criteria AND ability to randomize a minimum of 33% of all enrolled patients per year at each site \[i.e. randomize a minimum of 10% of all eligible neonates\]

  Through study completion (total 42 months)

• Fewer than 20% randomized subjects with protocol violations in High CPAP arm

  Defined as any use of NIPPV

  Through study completion (total 42 months)

• Fewer than 20% randomized subjects with protocol violations in NIPPV arm

  Defined as any use of high NCPAP \> 8 cmH2O

  Through study completion (total 42 months)

• Fewer than 20% of enrolled (consented, but pre-randomization) subjects with protocol violations

  Defined as post-consent initiation of high NCPAP or NIPPV for \>4 hours without randomization

  Through study completion (total 42 months)

Secondary Outcomes (15)

• Failure of assigned NRS mode within 7 days post-randomization

  7 days post-randomization

• Need for endotracheal ventilation at 72 hours and 7 days post-randomization

  72 hours and 7 days post-randomization

• Pre-discharge, in-hospital mortality

  Through to completion of initial hospitalization for each subject (estimated 40-44 weeks postmenstrual age)

• Bronchopulmonary dysplasia (BPD, based on NICHD criteria) (16) among survivors only

  until 36 weeks postmenstrual age

• Composite of pre-discharge mortality or BPD (latter as defined above)

  Through to completion of initial hospitalization for each subject (estimated 40-44 weeks postmenstrual age)

Study Arms (2)

High NCPAP

EXPERIMENTAL

Administration of high NCPAP (\> 8 cmH2O) following either failure of traditional NCPAP pressures (≤ 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure ≥10 cmH2O)

Other: Non-invasive respiratory support mode

NIPPV

ACTIVE COMPARATOR

Administration of NIPPV following either failure of traditional NCPAP pressures (≤ 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure ≥10 cmH2O)

Other: Non-invasive respiratory support mode

Interventions

Non-invasive respiratory support mode OTHER

A mode of providing respiratory support via nasal masks or prongs

High NCPAP; NIPPV

Eligibility Criteria

• Age: 72 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Major upper airway malformation (cleft lip/palate, severe micro-retrognathia, congenital tracheal stenosis or vascular ring, and neck mass/cystic hygroma)
• Major (non-airway) congenital abnormality not-yet repaired (congenital diaphragmatic hernia, abdominal wall defect, and tracheo-esophgeal fistulas)
• Suspected or confirmed chromosomal/genetic abnormality
• Administration of high NCPAP or NIPPV outside of randomization for greater than 4 continuous hours.

Sponsors & Collaborators

• McMaster Children's Hospital: lead
• Hamilton Academic Health Sciences Organization: collaborator
• Hamilton Health Sciences Foundation - New Investigator Fund: collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S4K1, Canada

RECRUITING

Related Publications (1)

• Mukerji A, Rempel E, Thabane L, Johnson H, Schmolzer G, Law BHY, Jani P, Tracy M, Rottkamp C, Keszler M, Kirpalani H, Shah PS; NOVEL Trial Group. High continuous positive airway pressures versus non-invasive positive pressure ventilation in preterm neonates: protocol for a multicentre pilot randomised controlled trial. BMJ Open. 2023 Feb 14;13(2):e069024. doi: 10.1136/bmjopen-2022-069024.

  PMID: 36787974 DERIVED

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Amit Mukerji, MD

CONTACT

905-521-2100; mukerji@mcmaster.ca

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: Associate Professor

Model Details: This pilot study will be an open-label, parallel arm, multi-centre randomized controlled trial with a 1:1 allocation ratio of individual patients in randomly varying blocks of 4, 6, or 8 stratified by centre and gestational age (\<26 weeks vs. ≥26 weeks GA). Neither investigators, nor bedside clinicians will be blinded due to the nature of the investigation, but allocation will be concealed by way of using an electronic randomization system (REDCap). This study will be conducted at 3 NICUs in North America and Australia: McMaster Children's Hospital (McMaster University, lead site), Royal Alexandra Hospital (University of Alberta), and Westmead Hospital (University of Sydney) with the possibility of additional centres joining. Moreover, outcome assessments will also not be blinded.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 30, 2018
• Study Start: May 15, 2018
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)