Pilot Prospective Unblinded Randomized Controlled Study Assessing the Efficacy and Safety of Physiologically Based Cord Clamping Versus Standard Delayed Cord Clamping After Elective Scheduled Cesarean Delivery of Full-term Newborn

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Belgium
CHU Brugmann
RECRUITING
Brussels
Hôpital Universitair Des Enfants Reine Fabiola
RECRUITING
Brussels
Contact Information
Primary
Anna AMORUSO
anna.amoruso@hubruxelles.be
+3224773250
Backup
Andrew CARLIN
andrew.carlin@chu-brugmann.be
+3224773295
Time Frame
Start Date: 2024-01-21
Estimated Completion Date: 2024-09
Participants
Target number of participants: 50
Treatments
Experimental: Physiological based cord clamping (PBCC)
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.
Active_comparator: Differed cord clamping (DCC)
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.
Sponsors
Leads: Queen Fabiola Children's University Hospital
Collaborators: Fonds IRIS-Recherche, Ars Statistica, The Belgian Kids Fund

This content was sourced from clinicaltrials.gov