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

Plain Language Summary

Simplified for easier understanding

This trial is studying a technique called "physiologically based cord clamping" (PBCC) — where doctors wait until the baby is breathing before cutting the umbilical cord — in moderate to late preterm babies (born between 32 and 37 weeks). The goal is to see if this approach improves outcomes for premature newborns. **You may be eligible if...** - You are pregnant and giving birth between 32 weeks 0 days and 36 weeks 6 days of pregnancy - You are carrying a single baby (not twins or more) - You are being followed at Brugmann University Hospital **You may NOT be eligible if...** - Your baby has a known abnormality, anemia, or growth restriction with abnormal blood flow - You have an abnormal placenta (e.g., placenta previa) - There are signs of fetal distress requiring emergency cesarean - You have severe anemia, preeclampsia, or bleeding disorders - You are having general anesthesia for a cesarean - You plan to donate the cord blood Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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