Improving neonatal outcomes with delayed cord clamping for preterm newborns
Prospective Unblinded Randomized Controlled Study Assessing the Physiologically Based Cord Clamping on Ventilation Duration in Moderate and Late Preterm
This study tests if waiting longer to clamp the umbilical cord can help improve health outcomes for moderate and late preterm newborns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 32 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Queen Fabiola Children's University Hospital Academic / other |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT06280872 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of physiologically based cord clamping on neonatal outcomes in moderate and late preterm newborns. The study focuses on the timing of umbilical cord clamping to enhance blood flow to the newborn, potentially improving respiratory function and reducing complications associated with premature birth. Pregnant women delivering between 32 and 36 weeks of gestation will be monitored to assess the impact of delayed cord clamping on various health outcomes. The methodology includes comparing standard practices with the physiological approach to cord clamping.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women expecting singletons between 32 and 36 weeks of gestation.
Not a fit: Patients with fetal anomalies, severe maternal health issues, or those requiring emergency cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce respiratory distress and other complications in preterm infants.
How similar studies have performed: Previous studies have shown promising results with delayed cord clamping in preterm infants, suggesting potential benefits in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant women followed-up in Brugmann University Hospital will be eligible to participate if: * The delivery takes place between 32 0/7 and 36 6/7 weeks of gestation * They carry singletons Exclusion Criteria: * Fetal anomalies including congenital malformations, anemia, and growth restriction with abnormal Dopplers. * Abnormal placentation such as placenta previa. * Signs of fetal distress necessitating an emergency cesarean section. * Maternal health issue including severe anemia (defined as hemoglobin level \< 7 g/dL), preeclampsia, and bleeding disorders. * Maternal refusal of the use of blood products. * General anesthesia for cesarian section. * Planned cord blood banking. * Total language barrier without possibility of translation
Where this trial is running
Brussels and 1 other locations
- CHU Brugmann — Brussels, Belgium (Recruiting)
- Hôpital Universitaire Des Enfants Reine Fabiola — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Anna AMORUSO — Huderf
- Study coordinator: Anna AMORUSO
- Email: anna.amoruso@hubruxelles.be
- Phone: +3224773250
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.