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

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.

Conditions

• Premature Birth
• Respiratory Distress Syndrome in Premature Infant
• Sepsis
• Intraventricular Hemorrhage of Prematurity
• Bronchodysplasia
• Jaundice

Interventions

OTHER

Physiological Based Cord Clamping

see Arm Description

OTHER

Differed Cord Clamping

see Arm Description

Sponsors & Collaborators

• The Belgian Kids Fund

  collaborator UNKNOWN

• Fonds IRIS-Recherche

  collaborator UNKNOWN

• Ars Statistica

  collaborator UNKNOWN

• Queen Fabiola Children's University Hospital

  lead OTHER

Principal Investigators

• Anna AMORUSO · HUDERF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

32 Weeks

Max Age

36 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-19

Primary Completion

2026-01-31

Completion

2026-07-31

Countries

• Belgium

Study Locations