Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-04 @ 10:30 AM
Study NCT ID:
NCT03852134
Status:
UNKNOWN
Last Update Posted:
2019-02-25
First Post:
2018-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Temperature stability', 'timeFrame': 'From randomization assessed up to 2 hours of age', 'description': 'Temperature on admission to NICU'}, {'measure': 'Need for advanced resuscitation at birth', 'timeFrame': 'From randomization assessed up to 2 hours of age', 'description': 'Need for advanced resuscitation including intubation, chest compressions and/or medications'}, {'measure': 'Inotropic support', 'timeFrame': 'From randomization assessed up to 72 hours of age', 'description': 'Need for inotropic medication support'}, {'measure': 'Volume expander', 'timeFrame': 'From randomization assessed up to 72 hours of age', 'description': 'Assess the need for a volume expander (saline bolus or albumin bolus)'}, {'measure': 'Cerebral oxygenation', 'timeFrame': 'From randomization assessed up to 72 hours of age', 'description': 'Measure the cerebral oxygenation using NIRS'}, {'measure': 'Blood transfusion', 'timeFrame': 'From randomization assessed up to 36 weeks corrected gestational age', 'description': 'Assess the number of blood transfusions baby received from birth'}, {'measure': 'Intraventricular hemorrhage (IVH)', 'timeFrame': 'From randomization assessed up to 36 weeks corrected age', 'description': 'Assess the grade of IVH'}, {'measure': 'Long-term outcomes', 'timeFrame': '24 Months Corrected age', 'description': 'Long-term neurodevelopmental outcomes at 18-24 months of corrected age.'}], 'primaryOutcomes': [{'measure': 'Rate of compliance to the study intervention', 'timeFrame': 'Two years', 'description': 'to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.'}, {'measure': 'Number of patients completing the study', 'timeFrame': 'Two years', 'description': 'To evaluate the number of patients who are recruited and completed the study to estimate the sample size needed for the design of a large multi-centre RCT.'}, {'measure': 'Number of adverse events associated with the MOCC intervention', 'timeFrame': 'Till the participants reach 2 year- corrected age (around 4.5 years)', 'description': 'To investigate any adverse events that could be attributed to the MOCC intervention.'}], 'secondaryOutcomes': [{'measure': 'Compare hemoglobin (Hgb) concentration', 'timeFrame': 'From date of randomization and assessed up to 24 hours of age', 'description': "to compare hemoglobin (Hgb) concentration on NICU admission in preterm infants \\<32 weeks' gestation who receive MOCC during resuscitation/stabilization following 30 seconds of DCC with those who receive DCC alone for 30-60 seconds at birth (standard practice-control group)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm infant', 'delayed cord clamping', 'cord milking', 'resuscitation'], 'conditions': ['Preterm Infant']}, 'referencesModule': {'references': [{'pmid': '39722339', 'type': 'DERIVED', 'citation': 'El-Naggar W, Mitra S, Abeysekera J, Disher T, Woolcott C, Hatfield T, McMillan D, Dorling J. Milking of the Cut Cord During Stabilization of Infants Born Very Premature: A Randomized Controlled Trial. J Pediatr. 2025 Mar;278:114444. doi: 10.1016/j.jpeds.2024.114444. Epub 2024 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'In this feasibility study, the investigators will randomize preterm infants born at \\<32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Preterm infants \\<32 weeks' gestation\n\nExclusion Criteria:\n\n* Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.\n* Monochorionic twins or any higher order multiple pregnancy\n* Major fetal congenital or chromosomal abnormality\n* Documented fetal anemia or in utero red blood cell transfusion\n* Intent to withhold or withdraw treatment of the infant"}, 'identificationModule': {'nctId': 'NCT03852134', 'acronym': 'MOCC', 'briefTitle': 'Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)', 'organization': {'class': 'OTHER', 'fullName': 'IWK Health Centre'}, 'officialTitle': 'Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)', 'orgStudyIdInfo': {'id': 'MOCC Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOCC Group', 'description': 'The OB provider will hold the baby at/below the placenta, provide warmth, stimulate the baby and suction the mouth/nose for 30 secs.S/He will then clamp and cut the cord about 5 cm from the the introitus (vaginal deliveries) or from the abdominal incision (C-Sections) before handing the baby with the long-cut cord to the neonatal team to resuscitate/ stabilize the baby. A member of the neonatal team will milk the long-cut cord slowly 1 time from the cut end toward the infant over 10 secs before clamping and cutting the cord 1-2 cm from the umbilical stump. The neonatal team will provide PPV to the baby (during the milking process) if the baby is not breathing. If the baby is breathing during the milking process the team will continue the stabilization as per standard NRP practice.', 'interventionNames': ['Procedure: MOCC Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DCC group', 'description': 'The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds.\n\nAfter these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.', 'interventionNames': ['Procedure: DCC Group']}], 'interventions': [{'name': 'MOCC Group', 'type': 'PROCEDURE', 'otherNames': ['Monitoring cerebral oxygenation by NIRS'], 'description': 'After 30 seconds of DCC, the cord will be clamped and cut 5 cm from the introitus in vaginal delivery or abdominal incision in the case of cesarean section before passing the infant with the long umbilical cord segment to the pediatric provider who will milk the cord one time towards the baby during resuscitation.', 'armGroupLabels': ['MOCC Group']}, {'name': 'DCC Group', 'type': 'PROCEDURE', 'otherNames': ['Monitoring cerebral oxygenation by NIRS'], 'description': 'The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds.\n\nAfter these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.', 'armGroupLabels': ['DCC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Walid El-Naggar, MD', 'role': 'CONTACT', 'email': 'walid.el-naggar@iwk.nshealth.ca', 'phone': '902-470-7961'}, {'name': 'Jon Dorling, MD', 'role': 'CONTACT', 'email': 'Jon.Dorling@iwk.nshealth.ca', 'phone': '902-470-6643'}], 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Walid El-Naggar, MD', 'role': 'CONTACT', 'email': 'walid.el-naggar@iwk.nshealth.ca', 'phone': '902-470-7961'}, {'name': 'Jon Dorling, MD', 'role': 'CONTACT', 'email': 'Jon.Dorling@iwk.nshealth.ca', 'phone': '902-470-6643'}], 'overallOfficials': [{'name': 'Walid El-Naggar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IWK Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator, Associate Professor of Pediatrics', 'investigatorFullName': 'Walid El-Naggar', 'investigatorAffiliation': 'IWK Health Centre'}}}}