RecruitingNot ApplicableNCT06280872

Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns

Prospective Unblinded Randomized Controlled Study Assessing the Physiologically Based Cord Clamping on Ventilation Duration in Moderate and Late Preterm


Sponsor

Queen Fabiola Children's University Hospital

Enrollment

180 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 32 WeeksMax Age: 36 Weeks

Inclusion Criteria3

  • 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 Criteria8

  • 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

Interventions

OTHERPhysiological Based Cord Clamping

see Arm Description

OTHERDiffered Cord Clamping

see Arm Description


Locations(2)

CHU Brugmann

Brussels, Belgium

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, Belgium

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NCT06280872


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