NCT06280872 Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns
| NCT ID | NCT06280872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Fabiola Children's University Hospital |
| Condition | Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-02-19 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.
Eligibility 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
Contact & Investigator
Anna AMORUSO
PRINCIPAL INVESTIGATOR
HUDERF
Frequently Asked Questions
Who can join the NCT06280872 clinical trial?
This trial is open to participants of all sexes, aged 32 Weeks or older, up to 36 Weeks, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06280872 currently recruiting?
Yes, NCT06280872 is actively recruiting participants. Contact the research team at anna.amoruso@hubruxelles.be for enrollment information.
Where is the NCT06280872 trial being conducted?
This trial is being conducted at Brussels, Belgium, Brussels, Belgium.
Who is sponsoring the NCT06280872 clinical trial?
NCT06280872 is sponsored by Queen Fabiola Children's University Hospital. The principal investigator is Anna AMORUSO at HUDERF. The trial plans to enroll 180 participants.