Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-25 @ 3:26 AM
Study NCT ID:
NCT03740594
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2018-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of KMC on Neurobehavior of Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2018-11-10', 'studyFirstSubmitQcDate': '2018-11-10', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)', 'timeFrame': 'the age of 36 weeks', 'description': 'applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9.'}, {'measure': 'Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)', 'timeFrame': 'the age of 36 weeks', 'description': 'applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9. For stress, lethargy, non-optimal response and asymmetic reflexes, the higher the seb-scale, the worse. In other sub-scales, the higher the scale, the better.'}], 'secondaryOutcomes': [{'measure': 'Salivary cortisol', 'timeFrame': '7 days', 'description': 'measuring salivary cortisol'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Neurobehavior']}, 'descriptionModule': {'briefSummary': 'This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable preterm neonates with gestational age between 31 and 35 weeks.\n\nExclusion Criteria:\n\n* Neonates with major congenital birth defects or chromosomal anomalies.\n* Perinatal asphyxia and intra-ventricular hemorrhage.\n* Hemodynamically significant cardiac abnormalities.\n* Neonates received postnatal steroids.\n* Neonates whose mothers had a history of drug abuse during pregnancy.'}, 'identificationModule': {'nctId': 'NCT03740594', 'briefTitle': 'Effect of KMC on Neurobehavior of Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates', 'orgStudyIdInfo': {'id': 'Effect of KMC on neurobehavior'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KMC 60 min group', 'interventionNames': ['Behavioral: KMC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KMC 120 min group', 'interventionNames': ['Behavioral: KMC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Behavioral: KMC']}], 'interventions': [{'name': 'KMC', 'type': 'BEHAVIORAL', 'description': 'Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.', 'armGroupLabels': ['KMC 120 min group', 'KMC 60 min group', 'control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dina Mohamed Mohamed Shinkar', 'investigatorAffiliation': 'Ain Shams University'}}}}