Evaluating non-invasive ventilation methods for preterm infants with respiratory distress

Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound

This study is testing different breathing support methods for premature babies with breathing problems to see which one helps them the best.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 1 Hour to 24 Hours
• Sex: All
• Sponsor: Alexandria University (Academic / other)
• Locations: 1 site (Alexandria)
• Trial ID: NCT06550219 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of various non-invasive ventilation methods, including nasal intermittent positive pressure ventilation (nIPPV), nasal continuous positive airway pressure (nCPAP), and nasal high flow cannula (NHFC), in managing respiratory distress in preterm neonates under 37 weeks gestational age. The primary focus is on the duration of non-invasive ventilation, while secondary outcomes include the need for intubation, duration of respiratory support, and assessment of lung function using lung ultrasound. The study aims to provide insights into the best practices for respiratory support in vulnerable newborns.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants under 37 weeks gestational age who are admitted to the NICU with signs of respiratory distress.

Not a fit: Patients with major congenital abnormalities or those requiring invasive mechanical ventilation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve respiratory management strategies for preterm infants, potentially reducing the need for invasive interventions.

How similar studies have performed: Similar studies have shown promise in using non-invasive ventilation techniques for preterm infants, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria: Preterm \<37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion Criteria:

1. Obvious major congenital abnormalities.
2. Any of the baby intubated for resuscitation or for other reasons.
3. Neonates need invasive mechanical ventilation.
4. Pulmonary hemorrhage.
5. Severe cardiovascular instability.
6. Cardiopulmonary arrest needing prolonged resuscitation.
7. Birth asphyxia (one-minute Apgar score ≤ 3).
8. Major cardiac diseases (not including patent ductus arteriosus).

Where this trial is running

Alexandria

• Alexandria university, Elshattbi hospital — Alexandria, Egypt (Recruiting)

Study contacts

• Study coordinator: Marwa M Farag, PhD

Conditions Preterm; Ventilator Lung; Newborn; preterm infants; non-invasive ventilation