Recruiting

Observational Study

Sponsor:

McMaster Children's Hospital

Code:

NCT03512158

Conditions

Preterm Infant

Respiratory Insufficiency Syndrome of Newborn

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-invasive respiratory support mode

Study Details

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

Study ID

NCT03512158

Start date

May 15, 2018

Status verified date

Dec, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Nov 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria: All preterm neonates with gestational age < 29 weeks with a chronological age of at least 72 hours admitted to one of three participating NICUs (McMaster Children's Hospital, Royal Alexandra Hospital, and Westmead Hospital); whose families have consented to study participation; and who do not meet any of the following exclusion criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High NCPAP

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)

active comparator: NIPPV

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)

Interventions

Non-invasive respiratory support mode

A mode of providing respiratory support via nasal masks or prongs

Primary outcome measure

  • Ability to enroll a minimum of 10% of all eligible neonates per year at each site [ Time Frame: Through study completion (total 42 months) ]
  • Fewer than 20% randomized subjects with protocol violations in High CPAP arm [ Time Frame: Through study completion (total 42 months) ]
  • Fewer than 20% randomized subjects with protocol violations in NIPPV arm [ Time Frame: Through study completion (total 42 months) ]
  • Fewer than 20% of enrolled (consented, but pre-randomization) subjects with protocol violations [ Time Frame: Through study completion (total 42 months) ]

Central Contacts and Locations

Central contacts

Amit Mukerji, MD

905-521-2100mukerji@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8S4K1

Contacts

Amit Mukerji, MD

9055212100mukerji@mcmaster.ca

More Information

Sponsor

McMaster Children's Hospital

Last update posted

Dec 16, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster Children's Hospital on 2022-12-16.