Using PEEP and EIT to keep lungs open in babies born before 32 weeks
EFFECT OF VARYING LEVELS OF PEEP ON PRETERM LUNG RECRUITMENT USING ELECTRICAL IMPEDANCE TOMOGRAPHY- FEASIBILITY STUDY
This study tests whether adjusting gentle breathing pressure (PEEP) guided by electrical impedance tomography (EIT) helps keep the lungs open in babies born before 32 weeks who need CPAP or ventilator support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | South Tees Hospitals NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Middlesbrough) |
| Trial ID | NCT06705257 on ClinicalTrials.gov |
What this trial studies
Preterm infants under 32 weeks who are receiving CPAP or mechanical ventilation are enrolled within their first two weeks of life. Investigators use electrical impedance tomography (EIT) to guide and compare different levels of positive end expiratory pressure (PEEP)/continuous distending pressure to find settings that best recruit the lungs without causing harm. Outcomes include measures of lung recruitment, need for or duration of mechanical ventilation, and safety events such as pneumothorax or skin issues. The intervention is performed at a single center with parental informed consent and excludes infants with major congenital anomalies, pneumothorax, high-frequency ventilation, or skin integrity concerns.
Who should consider this trial
Good fit: Ideal candidates are infants born before 32 weeks' gestation who are within their first two weeks of life, receiving CPAP or conventional mechanical ventilation, and whose parent(s) provide informed consent, without major congenital malformations or pneumothorax.
Not a fit: Infants with major congenital lung or heart malformations, existing pneumothorax, on high-frequency ventilation, or with skin integrity concerns (or those older than two weeks at screening) are unlikely to be enrolled or to benefit from this approach.
Why it matters
Potential benefit: If successful, EIT-guided PEEP could reduce the time very preterm infants need ventilator support and lower lung injury by tailoring pressure to each baby's lungs.
How similar studies have performed: EIT-guided PEEP has shown promising early results in adults and older children, but randomized and definitive evidence in very preterm infants is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Gestational age \<32 weeks based on mother's last menstrual period or first trimester ultrasound dating. 2. Receiving either CPAP or mechanical ventilation respiratory support. 3. Informed written consent from one of the parents. 4. Within the first two weeks of life. Investigators pragmatically chose this period, as there could be considerable lung injury after the first two weeks of life, making it difficult to test our hypothesis. Also, this time period would allow parents to settle down with their stressful preterm delivery and investigators could approach anytime within the first two weeks of life. Exclusion criteria 1. Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team. 2. Infants diagnosed with pneumothorax i. 3. Receiving high frequency mechanical ventilation. 4. Infants with concerns of skin integrity.
Where this trial is running
Middlesbrough
- South Tees NHS Trust — Middlesbrough, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Prakash Kannan Loganathan, MD
- Email: pkannanloganathan@nhs.net
- Phone: +447481492632
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.