Actively Recruiting

Phase Not Applicable
Age: 32Weeks - 36Weeks
All Genders
NCT06280872

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

Led by Queen Fabiola Children's University Hospital · Updated on 2024-03-05

180

Participants Needed

2

Research Sites

123 weeks

Total Duration

On this page

Sponsors

Q

Queen Fabiola Children's University Hospital

Lead Sponsor

T

The Belgian Kids Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 32Weeks - 36Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Delivery between 32 0/7 and 36 6/7 weeks of gestation
  • Single pregnancy (singleton)
  • Pregnant women followed-up at Brugmann University Hospital
Not Eligible

You will not qualify if you...

  • Fetal anomalies including congenital malformations, anemia, and growth restriction with abnormal Dopplers
  • Abnormal placentation such as placenta previa
  • Signs of fetal distress requiring emergency cesarean section
  • Maternal severe anemia (hemoglobin < 7 g/dL), preeclampsia, or bleeding disorders
  • Maternal refusal of blood products
  • General anesthesia planned for cesarean section
  • Planned cord blood banking
  • Total language barrier without possibility of translation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

CHU Brugmann

Brussels, Belgium, 1020

Actively Recruiting

2

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, Belgium, 1020

Actively Recruiting

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Research Team

A

Anna AMORUSO

CONTACT

A

Andrew CARLIN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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