Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-02 @ 7:44 AM
Study NCT ID:
NCT03885492
Status:
TERMINATED
Last Update Posted:
2023-10-25
First Post:
2019-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This was part of a University of Liverpool PhD programme, but PI suspended by University and left the programme. Also dismissed by sponsoring organisation SAfRI. Likely unreliable data so project abandoned with no plans to publish.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2019-03-16', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from 10 minutes in post-resuscitation temperature at 30 minutes', 'timeFrame': 'Between 10 and 30 minutes after birth', 'description': 'The researcher will measure post resuscitation temperatures at 10, 20 and 30 minutes afterbirth for babies not admitted to the neonatal unit after using the BabySaver.'}, {'measure': 'Number of procedures performed to newborns while on the BabySaver kit', 'timeFrame': 'at birth, upto 30 minutes', 'description': 'The researcher will list any resuscitation procedures or interventions provided to the newborns on the kit.'}, {'measure': 'change from childbirth in post-resuscitation temperature at admission to Neonatal unit.', 'timeFrame': 'Upon admission to Neonatal unit, up to 1 hour after birth', 'description': "For babies admitted to the neonatal unit, the baby's temperature will be measured on admission to the Neonatal unit"}], 'secondaryOutcomes': [{'measure': 'change from birth in Apgar score at 5 minutes', 'timeFrame': 'upto 5 minutes', 'description': 'Apgar score will be recorded at 1 minute and 5 minutes. Resuscitation of babies at birth will be performed in line with existing hospital guidelines.'}, {'measure': 'Demographic assessments', 'timeFrame': 'baseline', 'description': "Researchers will collect both mother's (age, marital status, education, occupation) and baby's demographic characteristics (sex, birth weight, gestation at birth)."}, {'measure': 'Design assessments transcripts', 'timeFrame': 'uptown 2 months', 'description': 'Researchers will collect data about design and practical aspects of the BabySaver kit from mothers, carers, midwives and doctors in form of audio and video recordings and extra notes. These will be transcribed verbatim for analysis using an NVivo qualitative software.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Birth Asphyxia', 'Neonatal Resuscitation', 'Maternal Distress']}, 'descriptionModule': {'briefSummary': 'To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa', 'detailedDescription': 'The BabySaver kit will be used for any delivery in which the baby requires resuscitation according to the hospital policy, national guidelines(Ministry of Health, 2016) and WHO policy(World Health Organization, 2014)\n\nThe target sample size for observation will be 30 babies requiring resuscitation at Mbale Regional Referral Hospital Delivery suite.\n\nThe researchers will observe midwives and mothers during the process of resuscitation. This will be a non-participant observation. The researchers will collect data on: demographics, the timing of cord clamping, time to establish ventilation, intervention provided on the kit, post-resuscitation temperature, need to move the baby to provide extra care, and notes of the ease of use or challenges experienced with the kit. The researchers will ask health workers for their views of the usability of the kit in comparison to the equipment in current use.\n\nThe researchers have developed a usability checklist to assess how health workers are using the BabySaver kit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The BabySaver kit will be used for any delivery in which the baby requires resuscitation according to the hospital policy, national guidelines(Ministry of Health, 2016) and WHO policy(World Health Organization, 2014). These include\n\n* Deliveries before 37 weeks of gestation\n* Deliveries with evidence of fetal distress from fetal monitoring\n* Instrumental deliveries\n* Deliveries in which there is a possibility of a life-threatening malformation\n* Deliveries in which meconium stained liquor has been noted.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* As this is the first delivery suite to use the kit in a clinical setting, we will include only low-risk babies in this study. Every low-risk birth that will need neonatal resuscitation will be selected and observations made for the use of the BabySaver resuscitation kit.\n\nExclusion Criteria:\n\n* High risk deliveries will be excluded, namely\n\n * babies born before 34 weeks' gestation,\n * babies with life threatening malformations or significant intrapartum asphyxia"}, 'identificationModule': {'nctId': 'NCT03885492', 'acronym': 'BabySaver', 'briefTitle': 'The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Sanyu Africa Research Institute'}, 'officialTitle': 'The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa', 'orgStudyIdInfo': {'id': 'BabySaver-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mbale', 'country': 'Uganda', 'facility': 'Mbale Regional Referral hospital', 'geoPoint': {'lat': 1.08209, 'lon': 34.17503}}], 'overallOfficials': [{'name': 'Andrew D Weeks, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Liverpool'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanyu Africa Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Liverpool', 'class': 'OTHER'}, {'name': 'Grand Challenges Canada', 'class': 'OTHER'}, {'name': 'Mbale Regional Referral Hospital', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}