Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 7:28 PM
Study NCT ID:
NCT06573333
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trails'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-24', 'studyFirstSubmitDate': '2024-08-24', 'studyFirstSubmitQcDate': '2024-08-24', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates', 'timeFrame': 'at 6 hours of life', 'description': 'Serum Calcium Levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Serum Calcium Concentration']}, 'descriptionModule': {'briefSummary': 'Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management.\n\nObjective: The objective is to determine the effects of early and delayed cord on serum calcium level in neonates Study Design: Randomized Controlled Trial', 'detailedDescription': 'Place and Duration of Study: PEMH Rawalpindi and CMH Rawalpindi from January 2024 to July 2024.\n\nPatients and Methods: Total sample size of 200 neonates will be included in the study divided into four groups with cord clamping at 15s, 30s, 60s, 120s each group will have a total of 50 neonates. Blood sampling for CBC / CRP / S. Electrolytes (Na, K, Total Ca, Ionized Ca, Mg), S Calcitonin, ABGs (HCO3 Levels) samples will be collected at 6 hours of life.\n\n* Inclusion Criteria: Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study\n* Exclusion Criteria: Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.\n\nExpected Results: Research data on serum Calcium levels in neonates have shown no correlation to timing of cord clamping. Same results are expected in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'minimumAge': '1 Minute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study\n\nExclusion Criteria:\n\n* Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.'}, 'identificationModule': {'nctId': 'NCT06573333', 'briefTitle': 'Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'College of Physicians and Surgeons Pakistan'}, 'officialTitle': 'Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates', 'orgStudyIdInfo': {'id': '369452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 seconds', 'description': 'Umbilical Cord will be clamped after 15s of birth and Serum calcium levels will be measured at 6 hours of life', 'interventionNames': ['Procedure: Umblical Cord Clamping']}, {'type': 'EXPERIMENTAL', 'label': '30seconds', 'description': 'Umbilical Cord will be clamped after 30s of birth and Serum calcium levels will be measured at 6 hours of life', 'interventionNames': ['Procedure: Umblical Cord Clamping']}, {'type': 'EXPERIMENTAL', 'label': '60seconds', 'description': 'Umbilical Cord will be clamped after 60s of birth and Serum calcium levels will be measured at 6 hours of life', 'interventionNames': ['Procedure: Umblical Cord Clamping']}, {'type': 'EXPERIMENTAL', 'label': '120 seconds', 'description': 'Umbilical Cord will be clamped after 120s of birth and Serum calcium levels will be measured at 6 hours of life', 'interventionNames': ['Procedure: Umblical Cord Clamping']}], 'interventions': [{'name': 'Umblical Cord Clamping', 'type': 'PROCEDURE', 'description': 'Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate', 'armGroupLabels': ['120 seconds', '15 seconds', '30seconds', '60seconds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'facility': 'Pak Emirates Military Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Umair Qureshi, MBBS', 'role': 'CONTACT', 'email': 'umairanees94@gmail.com', 'phone': '0519273480'}], 'overallOfficials': [{'name': 'Arshad Khushdil, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Hospital Rawalpindi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'College of Physicians and Surgeons Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Umair Anees Qureshi', 'investigatorAffiliation': 'College of Physicians and Surgeons Pakistan'}}}}