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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-36
SponsorQueen Fabiola Children's University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

The delivery takes place between 32 0/7 and 36 6/7 weeks of gestation

They carry singletons

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physiological Based Cord Clamping

    Other intervention

    see Arm Description

  • Differed Cord Clamping

    Other intervention

    see Arm Description

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Physiological Based Cord Clamping (PBCC)Experimental treatment 1 intervention
Group B: Differed Cord Clamping (DCC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of non-invasive or invasive respiratory support.

Time frame
from Birth to 28 days of life

Secondary outcomes

1

Rate of neonatal mortality

Time frame
within 28 days of delivery
2

Rate of neonatal resuscitation

Neonatal resuscitation is defined as the use of a T-piece resuscitator for continuous airway positive pressure or intermittent positive pressure (with or without oxygen supplementation).

Time frame
within first 10 minutes of life
3

Rate of neonatal respiratory morbidity

Neonatal respiratory morbidity includes respiratory distress syndrome, transient tachypnea of the newborn, air leak syndrome, and respiratory distress syndrome.

Time frame
from Birth to 28 days of life
4

Number of admission to the NICU or special care baby unit

Time frame
within first 72 hours of life

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Fabiola Children's University Hospital

Lead sponsor

The Belgian Kids Fund

Collaborator

Fonds IRIS-Recherche

Collaborator

Ars Statistica

Collaborator