Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06559020
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D066087', 'term': 'Perinatal Death'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study employs a quasi-experimental design with parallel assignment. Participants were self-selected into two groups: one receiving Kangaroo Mother Care (KMC) and the other receiving Conventional Care (CC). The intervention was applied without randomization, and both groups were followed for one year to assess differences in growth, developmental milestones, breastfeeding practices, vaccination status, and mortality among low birth weight and preterm infants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Breastfeeding', 'timeFrame': 'from 2 hours to 1 year', 'description': 'breastfeeding initiation within 2 hours, exclusive breastfeeding for 6 months, breastfeeding up to one year'}, {'measure': 'Number of babies with complete vaccination', 'timeFrame': '1 year', 'description': 'infant receiving all scheduled vaccinations within their first year of life'}, {'measure': 'Average weight of baby', 'timeFrame': '1 year', 'description': 'Weight of infant in Kg at birth, 6 weeks, 1 year, 6 months, and 1 year'}, {'measure': 'average length of infant', 'timeFrame': '1 year', 'description': 'Length of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year'}, {'measure': 'Average head circumference of infant', 'timeFrame': '1 year', 'description': 'Head circumference of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year'}, {'measure': 'Number of babies Holding head up', 'timeFrame': '3 months', 'description': 'baby able to hold their head up'}, {'measure': 'Number of babies Sitting without support', 'timeFrame': '6 months', 'description': 'Baby gets into sitting position without help'}, {'measure': 'Number of babies roll over', 'timeFrame': '8 months', 'description': 'baby able to roll from side to side'}, {'measure': 'Number of babies crawling', 'timeFrame': '10 months', 'description': 'baby able to move forward on hands and knees'}, {'measure': 'Number of babies babbles', 'timeFrame': '6 months', 'description': 'baby able to produce repititive incomprehensible sounds'}, {'measure': 'Number of babies produce 2 syllable sounds', 'timeFrame': '9 months', 'description': 'baby able to produce words that have two definite sounds'}, {'measure': 'cumulative Mortality rate', 'timeFrame': '1 year', 'description': 'Death of baby'}], 'secondaryOutcomes': [{'measure': 'Number of babies with Hypothermia', 'timeFrame': '72 hours', 'description': 'core body temperature less than 35 degree celsius'}, {'measure': 'Number of babies with Sepsis', 'timeFrame': '72 hours', 'description': 'infection leading to life threatening inflammatory response'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kangroo mother care', 'Infant development', 'Breast feeding', 'Neonatal death', 'Vaccination', 'Pakistan'], 'conditions': ['Low Birth Weight Infants', 'Preterm Infants']}, 'descriptionModule': {'briefSummary': 'This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. A total of 400 infants were enrolled and followed for one year.', 'detailedDescription': 'This quasi-experimental study was conducted in the Obstetrics and Gynecology Department of Services Institute of Medical Sciences (SIMS), Lahore, Pakistan, to compare the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on low birth weight infants. A total of 400 infants (200 in each group) born between January 2020 and December 2022 were included in the study, with participants selected based on specific inclusion criteria and informed consent obtained. KMC involved continuous skin-to-skin contact between mother and infant during the hospital stay and continued at home for at least 8 hours daily. The follow-up schedule included appointments at six weeks after birth, monthly visits until six months of age, and quarterly visits until the infants reached one year of age. During these visits, the study collected data on infant growth, developmental milestones, breastfeeding practices, and vaccination status. The study was ethically approved by the research ethics committee, and data collection was conducted during scheduled follow-up visits to the outpatient department.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women who were able to follow the program instructions,\n* permanent residents of Lahore and its periphery and willing to be part of program for the one-year time period,\n* live newborn babies delivered either vaginally or through caesarean section with birth weight of 1.5 to 2 kg,\n* gestational age between 28 to 36 weeks.\n\nExclusion Criteria:\n\n* an infant or mother diagnosed with a life-threatening ailment, major disease, or major malformations,\n* early-detected major conditions arising from perinatal problems, such as severe hypoxic-ischemic encephalopathy, pulmonary hypertension,\n* incidence of severe infection measured as nosocomial infections requiring systemic antibiotics or infections, severe respiratory distress, and hypothermia episodes (temperature less than 35C).'}, 'identificationModule': {'nctId': 'NCT06559020', 'briefTitle': 'Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Institute of Medical Sciences, Pakistan'}, 'officialTitle': 'Predictors for Opting for Kangaroo Mother Care in Pakistan and Infant Development Outcomes Based on a Quasi-Experimental Intervention', 'orgStudyIdInfo': {'id': 'IRB/2023/1099/SIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'kangroo mother care', 'description': 'he KMC group will receive continuous skin-to-skin contact between mother and infant for 24 hours a day, with support and training in kangaroo positioning and exclusive breastfeeding.', 'interventionNames': ['Behavioral: Kangroo mother care']}, {'type': 'NO_INTERVENTION', 'label': 'conventional care', 'description': 'The control group will receive conventional neonatal care, which includes placing newborns in open cots with appropriate heating or cooling based on weather conditions. Mothers will receive guidance on the benefits of exclusive breastfeeding and support to initiate breastfeeding, but will not have the structured kangaroo mother care provided to the experimental group.'}], 'interventions': [{'name': 'Kangroo mother care', 'type': 'BEHAVIORAL', 'description': 'Kangaroo Mother Care (KMC) involves continuous skin-to-skin contact between the mother (or another family member) and the infant, aimed at promoting thermal regulation, breastfeeding, and bonding. In this study, KMC was initiated in the hospital and continued at home for a minimum of 8 hours daily.', 'armGroupLabels': ['kangroo mother care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Institute of Medical sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Tayyiba Wasim, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Services Institute of Medical Sciences, Pakistan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Institute of Medical Sciences, Pakistan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Obstetrics & Gynaecology', 'investigatorFullName': 'Tayyiba Wasim', 'investigatorAffiliation': 'Services Institute of Medical Sciences, Pakistan'}}}}