Assessing lung recruitment in preterm infants using echocardiography and ultrasound
Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants Using High Frequency Ventilation
This study tests if a special breathing treatment can help preterm infants with breathing problems and compares using ultrasound to check their lungs instead of regular x-rays.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 1 Hour to 3 Days |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 2 sites (Alexandria and 1 other locations) |
| Trial ID | NCT05726578 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of high frequency oscillatory ventilation (HFOV) in improving lung recruitment in preterm infants aged 32 to 37 weeks with moderate to severe respiratory distress. It also compares the use of chest ultrasound for monitoring lung recruitment against traditional chest x-rays. Additionally, the study assesses cardiac hemodynamics through functional echocardiography to provide a comprehensive evaluation of the infants' respiratory and cardiac status.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants aged 32 to 37 weeks who exhibit signs of respiratory distress and require invasive respiratory support.
Not a fit: Patients with major congenital anomalies or congenital heart diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory support strategies for preterm infants, potentially leading to better outcomes in their recovery from respiratory distress.
How similar studies have performed: While the specific combination of interventions in this study may be novel, similar approaches using echocardiography and ultrasound in neonatal care have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants will be enrolled if they are 32 to 37 weeks of gestational age, have respiratory distress (RD) in the first 24 h of life, intubated and have invasive respiratory support using HFOV. Signs of RD are tachypnea (respiratory rate \> 60/min), grunting, nasal flaring, chest retraction, and need of oxygen supplementation or other respiratory support. Exclusion Criteria: 1. Known major congenital anomalies including congenital heart diseases. 2. Fetal hydrops. 3. Babies with congenital heart diseases
Where this trial is running
Alexandria and 1 other locations
- Marwa Mohamed Farag — Alexandria, Egypt (Recruiting)
- Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital. — Alexandria, Egypt (Not_yet_recruiting)
Study contacts
- Study coordinator: Marwa M Farag, PhD
- Email: d.marwa.farag@gmail.com
- Phone: 01288681788
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.