Non-invasive ventilation for preterm infants
Non-invasive Ventilation in Preterm Infants
NA · Universitair Ziekenhuis Brussel · NCT05987800
This study is testing a new breathing support method for preterm babies with breathing problems to see how well it helps them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 1 site (Jette, Brussel) |
| Trial ID | NCT05987800 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of non-invasive neurally adjusted ventilatory assist (NIV-NAVA) in preterm infants experiencing respiratory distress. It involves a prospective observational cohort design where data is collected through chart reviews and ventilatory data downloads. Participants will undergo a titration procedure followed by measurements using electrical impedance tomography and lung and diaphragm ultrasound to assess respiratory function. Caregivers will also evaluate the infants' respiratory severity scores during the weaning period.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 37 weeks of gestational age who require non-invasive respiratory support.
Not a fit: Patients who are full-term infants or those with major congenital malformations or chromosomal abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve respiratory support for preterm infants, potentially reducing complications associated with invasive ventilation.
How similar studies have performed: Other studies have shown promise in using non-invasive ventilation techniques for preterm infants, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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...)
Where this trial is running
Jette, Brussel
- Universitair Ziekenhuis Brussel — Jette, Brussel, Belgium (RECRUITING)
Study contacts
- Principal investigator: Julie Lefevere, MD — Universitair Ziekenhuis Brussel
- Study coordinator: Julie Lefevere, MD
- Email: julie.lefevere@uzbrussel.be
- Phone: 024777721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Birth, Respiratory Distress Syndrome, Ventilator Lung, Newborn