Status:

ACTIVE_NOT_RECRUITING

Non-invasive Ventilation in Preterm Infants

Lead Sponsor:

Universitair Ziekenhuis Brussel

Conditions:

Premature Birth

Respiratory Distress Syndrome

Eligibility:

All Genders

Phase:

NA

Brief Summary

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data...

Eligibility Criteria

Inclusion

  • Preterm infants (\< 37 weeks GA) supported with non-invasive respiratory support for at least 24 hours. Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous positive airway pressure (nCPAP) or high flow nasal canula (flow \> 2 liters/min).The support can be given as primary respiratory support or as respiratory support after weaning from invasive ventilation (= after extubation).
  • Infants can only be enrolled after written and signed informed consent by the parents.

Exclusion

  • Infant born after a gestational age of 37 weeks or more.
  • Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia…)

Key Trial Info

Start Date :

February 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2025

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT05987800

Start Date

February 1 2023

End Date

September 30 2025

Last Update

September 26 2025

Active Locations (1)

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium, 1090