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

NCT06280872 | Recruiting

• 1 other identifier: P2023/Neonat/PhyCordPrem
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Moderate and late preterm newborn; Neonatal respiratory morbidity; Physiological based-cord clamping; Mother-infant bonding

Outcome Measures

Primary Outcomes (1)

• Duration of non-invasive or invasive respiratory support.

  from Birth to 28 days of life

Secondary Outcomes (25)

• Rate of neonatal mortality

  within 28 days of delivery

• Rate of neonatal resuscitation

  within first 10 minutes of life

• Rate of neonatal respiratory morbidity

  from Birth to 28 days of life

• Number of admission to the NICU or special care baby unit

  within first 72 hours of life

• Length of hospitalization

  Up to 8 weeks post delivery

Study Arms (2)

Physiological Based Cord Clamping (PBCC)

EXPERIMENTAL

In the intervention group, newborns will receive PBCC. The resuscitation table will be placed as close as possible to the mother's pelvis. Stabilization will start as soon as the infant is placed on the platform. The nurse will place the oximeter sensor on the right wrist, electrocardiogram electrodes on the chest of the newborn. Local resuscitation guidelines will be in respect of the Newborn Life support European Resuscitation Council 2021 guidelines. Stabilization of the newborn will be performed while the cord is intact and the cord will be clamped after respiratory stabilization will be achieved, de fined as the establishment of regular spontaneous breathing, a heart rate above 100 bpm and oxygen saturation by pulse oximetry above 85% while using supplemental oxygen less than 0,4. If the infant does not reach the criteria for being stable, the maximum clamping time will be 10 min. After clamping, the platform will be withdrawn and placed next to the bed of the mother.

Other: Physiological Based Cord Clamping

Differed Cord Clamping (DCC)

ACTIVE COMPARATOR

In the control group, newborns will receive standard DCC defined as time based and performed at 60 seconds after birth, depending on the clinical condition of the infant, in accordance with the ERC guidelines 2021.Then infants will be transferred to a standard resuscitation table located in a stabilization room next to the operating room. Further treatment and intervention required for cardiopulmonary stabilization will be provided on the standard resuscitation table. Stabilization will start as soon as the infant is placed on the resuscitation table. The nurse will place the oximeter sensor on the right wrist, ECG electrodes on the chest and temperature probe on the right hypochondrium of the newborn. Local resuscitation guidelines will be in respect of the Newborn Life support European Resuscitation Council 2021 guidelines. The time to reach the stabilisation described above (a HR above 100 bpm and SpO 2 above 85% while using supplemental oxygen less than 0,4) is recorded.

Other: Differed Cord Clamping

Interventions

Physiological Based Cord Clamping OTHER

see Arm Description

Physiological Based Cord Clamping (PBCC)

Differed Cord Clamping OTHER

see Arm Description

Differed Cord Clamping (DCC)

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead
• The Belgian Kids Fund: collaborator
• Fonds IRIS-Recherche: collaborator
• Ars Statistica: collaborator

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Premature Birth; Sepsis; Jaundice; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia; Skin Manifestations; Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Anna AMORUSO

  HUDERF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna AMORUSO

CONTACT

+3224773250; anna.amoruso@hubruxelles.be

Andrew CARLIN

CONTACT

+3224773295; andrew.carlin@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 28, 2024
• Study Start: February 19, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

BE (2)