protocolSection identificationModule nctId: NCT06278415, orgStudyIdInfo id: P2021/Neonat/PhyCord 1, briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery, acronym: PhyCord1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-21, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Queen Fabiola Children's University Hospital, class: OTHER, collaborators name: The Belgian Kids Fund, collaborators name: Fonds IRIS-Recherche, collaborators name: Ars Statistica, descriptionModule briefSummary: 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., conditionsModule conditions: Transient Tachypnea of the Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Physiological based cord clamping, interventions name: Differed cord clamping, outcomesModule primaryOutcomes measure: Rate of neonatal mortality, primaryOutcomes measure: Rate of neonatal resuscitation, primaryOutcomes measure: Rate of neonatal respiratory morbidity, primaryOutcomes measure: Number of admission to the NICU or special care baby unit, secondaryOutcomes measure: Success of PBCC, secondaryOutcomes measure: Time to first breath/cry, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Early neonatal parameters, secondaryOutcomes measure: Early neonatal parameters, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Bilirubin level, secondaryOutcomes measure: Number of neonatal adverse events, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Number of maternal adverse events, secondaryOutcomes measure: Rate of maternal-infant bonding, secondaryOutcomes measure: Rate of maternal-infant bonding, secondaryOutcomes measure: Rate of maternal-infant bonding, secondaryOutcomes measure: Child developmental assessment, secondaryOutcomes measure: Parental satisfaction survey, eligibilityModule sex: ALL, minimumAge: 37 Weeks, maximumAge: 42 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: CHU Brugmann, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Andrew CARLIN, role: CONTACT, phone: +3224773295, email: andrew.carlin@chu-brugmann.be, contacts name: Andrew CARLIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Hôpital Universitair Des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Anna AMORUSO, role: CONTACT, phone: +3224773250, email: anna.amoruso@hubruxelles.be, contacts name: Anna AMORUSO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False