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Clinical trial Recruiting at 1 site Observational Ages 3 Days and up

Breathing support methods for preterm infants

Official title: Respiratory Support and Brain Health in Preterm Infants: a Prospective Crossover Study

Run by Mount Sinai Hospital, Canada · NCT05589831 · Data updated 2026-11-12

This study is testing whether a new breathing support method for preterm infants can help them sleep better and stay healthier compared to the standard method.

Quick facts

Study typeObservational
Ages3 Days and up
SexAll
Enrollment50 (estimated)
SponsorMount Sinai Hospital, Canada
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedJuly 4, 2023
Main results expectedDecember 2025
Study endsJanuary 2026
Registry record updatedMarch 24, 2025
Trial IDNCT05589831 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are preterm infants born between 22 and 31 weeks gestation who are clinically stable and receiving non-invasive breathing support.

Probably not a fit

Patients with severe brain injuries, congenital abnormalities, or those who do not meet the stability criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares two methods of non-invasive breathing support in preterm infants born under 32 weeks gestation. The focus is on Neurally Adjusted Ventilatory Assist (NIV-NAVA) versus standard Non-Invasive Positive Pressure Ventilation (NIPPV) to assess their effects on sleep-wake cycling, cerebral oxygenation, heart rate variability, and diaphragm function. The study aims to determine if NIV-NAVA provides better neuroprotection and comfort for these vulnerable infants during their critical period of development.

Why it matters

Potential benefit: If successful, this study could lead to improved respiratory support techniques that enhance brain development in preterm infants.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving outcomes for preterm infants with non-invasive ventilation techniques.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Preterm infants born between 22+0 and 31+6 weeks' GA
* Weight \> 500 g at the time of approach for consent
* A minimum of 3 days of age
* Clinically stable for \> 24 hours while receiving NIPPV or NIV-NAVA

Clinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment:

1. differences in maximum and minimum fractions of inspired oxygen (FiO2) of \<20%
2. differences in maximum and minimum MAP \<4 cm H2O
3. no active infection
4. no hypotension
5. no use of cardioactive medications or medical therapy for patent ductus arteriosus.

Exclusion Criteria:

* Infants with IVH of grade 3 or 4
* Birth weight \< 3rd percentile
* Genetic or congenital abnormalities

Where it's running

  • Mount Sinai Hospital
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Cerebral Oxygenation 11Mount Sinai Hospital, Canada 22
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.