Evaluating non-invasive ventilation methods for preterm infants with respiratory distress
Official title: Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound
Run by Alexandria University · NCT06550219 · Data updated 2026-11-12
This study is testing different breathing support methods for premature babies with breathing problems to see which one helps them the best.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Hour to 24 Hours |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | November 20, 2024 |
| Main results expected | May 28, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | February 4, 2025 |
| Trial ID | NCT06550219 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with major congenital abnormalities or those requiring invasive mechanical ventilation will 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 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.
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 gone: Similar studies have shown promise in using non-invasive ventilation techniques for preterm infants, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Alexandria university, Elshattbi hospital
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Marwa M Farag, PhD
- Email: d.marwa.farag@gmail.com
- Phone: 01288681788
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
NeoBellyBand abdominal support for premature infants on CPAP
We will try the FDA-approved DandleLion NeoBellyBand on premature infants needing CPAP to see if it thickens their rectus abdominis muscle and helps them reach full oral feedings sooner.
-
Adjusting ventilator PEEP to improve lung compliance and heart function in preterm infants
We will try changing the ventilator's PEEP settings in babies born before 34 weeks who need breathing support to see if the PEEP that gives the best lung compliance improves heart output and oxygen levels.
-
Caffeine treatment for late preterm infants with breathing difficulties
This study tests if giving caffeine to late preterm infants with breathing problems can help them breathe better and shorten their hospital stay.
-
Premature infants: trying PIOMI with mom to support feeding
Aims to see if PIOMI done with a mother’s presence and voice helps preterm babies feed better and feel more connected to mom.
-
Dry Cord Care vs Alcohol Cord Care for Healthy Newborns
This trial tests whether dry cord care or routine alcohol cord care is better for healthy newborns by looking at infection rates in the umbilical cord.
-
Breathing before breastfeeding to help moms of NICU babies
This study tests whether pre-breastfeeding breathing exercises can reduce anxiety and improve well-being for mothers with babies in the NICU.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.