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