protocolSection identificationModule nctId: NCT06280872, orgStudyIdInfo id: P2023/Neonat/PhyCordPrem, briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns, acronym: PhyCordPrem, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-05, 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.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., conditionsModule conditions: Premature Birth, conditions: Respiratory Distress Syndrome in Premature Infant, conditions: Sepsis, conditions: Intraventricular Hemorrhage of Prematurity, conditions: Bronchodysplasia, conditions: Jaundice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Physiological Based Cord Clamping, interventions name: Differed Cord Clamping, outcomesModule primaryOutcomes measure: Duration of non-invasive or invasive respiratory support., secondaryOutcomes measure: Rate of neonatal mortality, secondaryOutcomes measure: Rate of neonatal resuscitation, secondaryOutcomes measure: Rate of neonatal respiratory morbidity, secondaryOutcomes measure: Number of admission to the NICU or special care baby unit, secondaryOutcomes measure: Length of hospitalization, secondaryOutcomes measure: Gestational age corrected at discharge, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Early neonatal parameters, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Bilirubin level, secondaryOutcomes measure: Occurrence of Neonatal adverse events, secondaryOutcomes measure: Biological markers of oxidative stress, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal postoperative hemoglobin level, secondaryOutcomes measure: Number of maternal adverse events, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Rate of Maternal-infant bonding, secondaryOutcomes measure: Rate of Maternal-infant bonding, secondaryOutcomes measure: Rate of Maternal-infant bonding, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Parental satisfaction survey, secondaryOutcomes measure: Child development assessment, secondaryOutcomes measure: Success of PBCC, eligibilityModule sex: ALL, minimumAge: 32 Weeks, maximumAge: 36 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 Universitaire Des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Anna AMORUSO, MD, role: CONTACT, phone: +3224773250, email: anna.amoruso@hubruxelles.be, contacts name: Anna AMORUSO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False