Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:56 PM
Study NCT ID:
NCT07482904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Interventional Program on Low Birth Weight Baby Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Mothers in this group will receive a structured home-based educational program focusing on Low Birth Weight (LBW) care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LBW babies health outcome', 'timeFrame': 'The 2-weeks and 3 months after home intervention period.', 'description': 'Primary Outcome:\n\n1-Total weight gain(in grams) from baseline (discharge) to the end of the 2-week and 3 months after home intervention period.'}, {'measure': 'LBW babies health outcome', 'timeFrame': 'The 2-weeks and 3 months after home intervention period.', 'description': '2-Mean Body Temperature, pulse, and respiratory rate to assess the efficacy of thermal care and Skin-to-Skin contact.'}], 'secondaryOutcomes': [{'measure': "Improvement in mothers' knowledge and performance", 'timeFrame': '2 week after home-based interventional program and 3 months after home-based interventional program.', 'description': 'Secondary Outcome\n\n1. Maternal Knowledge Unit of Measure: Score on a scale of 0 to 75 (Higher scores indicate higher levels of knowledge).\n\n Outcome Measure\n2. Maternal Performance Unit of Measure: 0-75%(Higher scores indicate better adherence to neonatal car'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Birth Weight', 'Home-Based Intervention', 'Mother Knowledge', 'Mother Performance', 'Home care', 'Thermoregulation', 'Infection prevention', 'Erbil'], 'conditions': ['Low Birth Weight Baby', 'Very Low Birth Weight Baby']}, 'descriptionModule': {'briefSummary': "The goal of this interventional study is to evaluate whether a home-based interventional program for mothers can improve their knowledge and performance in caring for their low birth weight baby at home. The study focus on LBW babies, Particularly \\[ Low Birth Weight baby who their weight less than 2500g and Very Low Birth Weight babies who their weight less than 1500g\\], and aims to determine that home based interventional program will improve the health outcome of low birth weight babies.\n\nThe main questions it aims to answer are:\n\n1. How do home-based intervention programs improve mothers' performance and associated health outcomes in the care of low birth weight (LBW) infants?\n2. How effective is a home-based intervention program in improving mothers' knowledge regarding low birth weight (LBW) baby care in Erbil during 2025-2026?", 'detailedDescription': "This interventional study aims to explore the effectiveness of home-based interventional program on mothers' performance concerning low birth weight baby care.In Erbil City, many mothers of LBW infants lack adequate support mechanisms after hospital discharge, leading to suboptimal care practices and infant health outcomes. This study will assess the role of home interventional program on improving mother's knowledge, performance, and enhancing LBW infant health outcome.\n\nThe study will involve two groups of mothers with Low Birth weight baby:\n\nIntervention Group: Mothers will receiving structured home-based interventional program regarding thermoregulation, skin to skin contact, breastfeeding, umbilical care, skin care, infection prevention, and recognizing danger signs at home.\n\nControl Group: Mothers will not receiving structured home-based interventional program regarding thermoregulation, skin to skin contact, breastfeeding, umbilical care, skin care, infection prevention, and recognizing danger signs at home.\n\nThe home-based interventional program will cover the following...\n\n* Perform home care management regarding thermoregulations\n* Know the way of heat loss among newborns\n* List the benefits of skin-to-skin contact for mothers and babies.\n* Demonstrate skin to skin contact care.\n* Explain the benefits of breastfeeding for mothers and babies.\n* Apply home care management regarding breastfeeding.\n* Model ways of expressing breast milk.\n* Practice cup feeding for low birth weight baby at home.\n* Illustrate home care management regarding infection prevention.\n* Perform home care management regarding skin and umbilical care.\n* Describe home care management regarding recognizing danger signs.\n\nData will collect by the following techniques:\n\n1. All mothers (control and intervention groups) will interview for explaining the purpose of the study.\n2. All mothers in (control and intervention groups) will expose to the pre-test in order to detect the knowledge and performance of mothers.\n3. All mothers of the (intervention group) will expose to home based interventional program.\n4. All mothers in (control group) will not expose to home based interventional program.\n5. All mothers in (control and intervention groups) will expose to post-test, approximately two weeks after the implementation of the program.\n6. All mothers in (control and intervention groups) will expose to post-test, approximately three months after the implementation of the program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Low birth weight\\< 2500gram\n\nExclusion Criteria:\n\n1. extremely low birth weight (\\<1000gram).\n2. Orphan children (mother's die).\n3. Baby with congenital anomalies."}, 'identificationModule': {'nctId': 'NCT07482904', 'acronym': '(HBEP-LBWC)', 'briefTitle': 'Home-based Interventional Program on Low Birth Weight Baby Care', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': "Effectiveness of Home-based Interventional Program on Mothers' Performance Concerning Low Birth Weight Baby Care in Erbil City", 'orgStudyIdInfo': {'id': 'HawlerMUErbil\\Iraq'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Compare group or Control group', 'description': 'in this group it only doing routine cares, this includes any customary facility-based counseling provided at the time of birth or during scheduled follow-up visits.'}, {'type': 'EXPERIMENTAL', 'label': 'Home- based interventional group', 'description': 'Participants assigned to this intervention arm will be enrolled in a structured, home-based educational program designed to optimize neonatal outcomes through the promotion of evidence-based caregiving practices.', 'interventionNames': ['Other: Home-based Interventional group']}], 'interventions': [{'name': 'Home-based Interventional group', 'type': 'OTHER', 'description': 'Participants assigned to this intervention arm will be enrolled in a structured, home-based educational program designed to optimize neonatal outcomes through the promotion of evidence-based caregiving practices.\n\nIncluding\n\n1. Prioritizes thermal regulation and prolonged skin-to-skin contact (Kangaroo Mother Care) to mitigate the risks of neonatal hypothermia.\n2. Provides intensive instruction on exclusive breastfeeding,\n3. Hygienic umbilical cord and skin maintenance,\n4. Stringent infection control measures.\n\nA critical component of the intervention involves empowering caregivers with the clinical literacy required for the early recognition of neonatal danger signs, thereby facilitating timely care-seeking behaviors. By transitioning these interventions into the domiciliary environment, the program seeks to bridge the gap between facility-based birth and long-term health stability for Low Birth Weight (LBW) infants.', 'armGroupLabels': ['Home- based interventional group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erbil', 'country': 'Iraq', 'facility': 'Hawler Medical Unversity', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}], 'overallOfficials': [{'name': 'Hawler Medical Unversity College of Nursing', 'role': 'STUDY_CHAIR', 'affiliation': 'Hawler Medical university/College of Nursing, Erbil, Kurdistant Region, Iraq, 44001'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'because I am a Phd student, it is special for me.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chawarwan Saleem Abdullah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hawler Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Chawarwan Saleem Abdullah', 'investigatorAffiliation': 'Hawler Medical University'}}}}