Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-27 @ 3:03 PM
Study NCT ID:
NCT05955404
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kangroo Mother Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D060127', 'term': 'Kangaroo-Mother Care Method'}], 'ancestors': [{'id': 'D056888', 'term': 'Patient Positioning'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007224', 'term': 'Infant Care'}, {'id': 'D002654', 'term': 'Child Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premature Infant Pain Profile-Revised (PIPP-R)', 'timeFrame': 'Two months', 'description': 'The Premature Infant Pain Profile-Revised (PIPP-R) measures the intensity of pain that the preterm infants experience in NICU through infant indicators (change in heart rate from baseline, decrease in oxygen saturation from baseline, browse bulge, eye squeeze, and naso-labial furrow. It also includes gestational age and behavioral state.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth Complication']}, 'descriptionModule': {'briefSummary': 'infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.', 'detailedDescription': 'infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs and comparing the pain intensity with preterm infants who receive conventional care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '32 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants whose corrected gestational age from (32 - \\<37) weeks of pregnancy\n* Preterm infants who do not experience any painful procedure for last 24 hours\n* Preterm infants do not receive any sedation for last 24 hours\n\nExclusion Criteria:\n\n* full-term infants whose corrected gestational age is \\>37 weeks\n* extremely preterm (\\< 28 weeks)\n* very preterm (28-\\<32 weeks)\n* proven or suspected sepsis\n* major congenital malformations\n* all heart defect except neonatal Patent ductus arteriosus (PDA)\n* necrotizing enterocolitis\n* neurodevelopmental disability\n* who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure, or high-flow support\n* indicated for surgery\n* contraindication to oral sucrose\n* Twins\n* infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs'}, 'identificationModule': {'nctId': 'NCT05955404', 'briefTitle': 'Kangroo Mother Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': "Effect of Kangaroo Mother Care in Alleviating Preterm Infant's Pain", 'orgStudyIdInfo': {'id': 'kangroo mother care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kangaroo mother care', 'description': 'This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.', 'interventionNames': ['Other: Kangaroo mother care']}], 'interventions': [{'name': 'Kangaroo mother care', 'type': 'OTHER', 'description': 'This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.', 'armGroupLabels': ['Kangaroo mother care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14149', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'College of Nursing- The University of Baghdad', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hiba Abdulwahid Dawood', 'investigatorAffiliation': 'University of Baghdad'}}}}