Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery

NCT06278415 | Recruiting

• 1 other identifier: P2021/Neonat/PhyCord 1
• Study Type: interventional
• Target: 50
• 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. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. 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 cesarean section 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 term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.

Conditions

Transient Tachypnea of the Newborn

Keywords

Full-term baby; Scheduled c-section; Neonatal respiratory morbidity; Physiological based-cord clamping

Outcome Measures

Primary Outcomes (4)

• Rate of neonatal mortality

  within 28 days of delivery

• 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).

  within first 10 minutes of life

• Rate of neonatal respiratory morbidity

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

  within first 24 hours of life

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

  within first 72 hours of life

Secondary Outcomes (23)

• Success of PBCC

  within first 10 minutes of life

• Time to first breath/cry

  post delivery

• Changes in physiological variables during neonatal transition

  within first 10 minutes of life

• Changes in physiological variables during neonatal transition

  within first 10 minutes of life

• Changes in physiological variables during neonatal transition

  within first 10 minutes of life

Study Arms (2)

Physiological based cord clamping (PBCC)

EXPERIMENTAL

In the intervention group, newborns will receive PBCC. The resuscitation table will place in the operating room as close as possible to the mother's pelvis. After the infant is born, the obstetrician holds the infant. Stabilization will start as soon as the infant is placed on the platform. The nurse places the oximeter sensor on the right wrist and ECG electrodes on the chest of the newborn. Local resuscitation guidelines will be in respect of the NLS-ERC 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, defined as the establishment of regular spontaneous breathing, a HR above 100 bpm SpO 2 above 85% while using supplemental oxygen less than 0,3.

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. 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 and ECG electrodes on the chest of the newborn. Local resuscitation guidelines will be in respect of the NLS-ERC 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 0,3) is recorded. Then, the infant will be placed on the mother's chest or partner's chest, or alternatively, be prepared and transferred to the transport incubator if further neonatal care is needed.

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: 37 Weeks - 42 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:
• Scheduled for cesarean delivery (business days and daily working hours)
• Singleton pregnancy
• Cesarean section scheduled at or after 37 weeks gestational age

You may not qualify if:

• Fetal anomalies (congenital malformations, anemia, growth restriction with abnormal Dopplers)
• Abnormal placentation (placenta previa)
• Signs of fetal distress necessitating an emergency cesarean section
• Spontaneous labor before 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 Universitair Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 26, 2024
• Study Start: January 21, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

BE (2)