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Search / Trial NCT05987800

Non-invasive Ventilation in Preterm Infants

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Aug 3, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of breathing support called non-invasive neurally adjusted ventilatory assist (NIV-NAVA) for preterm infants who have difficulty breathing. The researchers want to see how well this method helps these babies compared to other types of non-invasive breathing support, like nasal continuous positive airway pressure (nCPAP) or high-flow nasal cannula. The study will collect information about how the babies are doing while they receive this support, including how much effort they need to breathe.

To be eligible for this trial, infants must be born prematurely (before 37 weeks of pregnancy) and must have been on some form of non-invasive breathing support for at least 24 hours. Parents will need to give their written consent for their baby to participate. During the trial, caregivers will closely monitor the babies, checking their breathing every two hours and conducting some tests using imaging technology to see how their lungs and diaphragm are working. This study is currently recruiting participants, and it’s an important step in finding better ways to help preterm infants with breathing problems.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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...)

About Universitair Ziekenhuis Brussel

Universitair Ziekenhuis Brussel (UZ Brussel) is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution affiliated with the Vrije Universiteit Brussel, UZ Brussel integrates cutting-edge medical research with high-quality patient care. The hospital's multidisciplinary teams are dedicated to exploring novel therapeutic approaches and contributing to the development of evidence-based treatments, ensuring the highest standards of safety and efficacy in clinical research. With a strong focus on collaboration and knowledge dissemination, UZ Brussel plays a pivotal role in shaping the future of medicine and improving patient outcomes.

Locations

Jette, Brussel, Belgium

Patients applied

0 patients applied

Trial Officials

Julie Lefevere, MD

Principal Investigator

Universitair Ziekenhuis Brussel

Filip Cools, PhD

Study Director

Universitair Ziekenhuis Brussel

Brenda Van Delft, Nurse

Study Chair

Universitair Ziekenhuis Brussel

Caitlin Jansen, Student

Study Chair

Vrije Universiteit Brussel

Lissa De Potter, MD

Study Chair

Universitair Ziekenhuis Brussel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported