Monitoring brain oxygen levels in preterm infants during cord management
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm (COSMIC Pilot Study)
This study is testing if a special tool can help measure brain oxygen levels in preterm babies right after birth to see how delaying cord clamping for a minute affects their oxygenation and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 1 Minute to 24 Hours |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06526091 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the feasibility of using Near Infrared Spectroscopy (NIRS) to measure cerebral oxygen saturation in preterm infants immediately after delivery. The focus is on assessing the effects of optimal cord management, defined as delaying umbilical cord clamping for one minute, on cerebral oxygenation. By monitoring brain oxygen levels during this critical period, the study aims to generate data that could inform the best timing for cord clamping in preterm infants, who are at risk of brain injury if clamped too early. The study will also analyze changes in heart rate and peripheral oxygen saturation during placental transfusion and cord clamping.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born before 34 weeks gestational age who are eligible for optimal cord management.
Not a fit: Patients who may not benefit include those with multiple pregnancies, severe congenital anomalies, or complex congenital cardiac disease.
Why it matters
Potential benefit: If successful, this study could improve outcomes for preterm infants by optimizing the timing of cord clamping to enhance cerebral oxygenation.
How similar studies have performed: While the use of NIRS for monitoring cerebral oxygenation is established, this specific approach to cord management in preterm infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All babies eligible for optimum cord management born before 34 completed weeks gestational age * Parental consent Exclusion Criteria: * Multiple pregnancies * Infants for whom resuscitation at birth is not appropriate * Antenatal or immediate postnatal diagnosis of severe congenital anomaly * Infants with complex congenital cardiac disease
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jayanta Banerjee, MD (Res) — Imperial College Healthcare NHS Trust
- Study coordinator: Jayanta Banerjee, MD (Res)
- Email: jayanta.banerjee@nhs.net
- Phone: 07771826045
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.