- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885492
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda (BabySaver)
The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
Study Overview
Status
Detailed Description
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)
The target sample size for observation will be 30 babies requiring resuscitation at Mbale Regional Referral Hospital Delivery suite.
The 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.
The researchers have developed a usability checklist to assess how health workers are using the BabySaver kit.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Mbale, Uganda
- Mbale Regional referral Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
- Deliveries before 37 weeks of gestation
- Deliveries with evidence of fetal distress from fetal monitoring
- Instrumental deliveries
- Deliveries in which there is a possibility of a life-threatening malformation
- Deliveries in which meconium stained liquor has been noted.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
High risk deliveries will be excluded, namely
- babies born before 34 weeks' gestation,
- babies with life threatening malformations or significant intrapartum asphyxia
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from 10 minutes in post-resuscitation temperature at 30 minutes
Time Frame: Between 10 and 30 minutes after birth
|
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.
|
Between 10 and 30 minutes after birth
|
Number of procedures performed to newborns while on the BabySaver kit
Time Frame: at birth, upto 30 minutes
|
The researcher will list any resuscitation procedures or interventions provided to the newborns on the kit.
|
at birth, upto 30 minutes
|
change from childbirth in post-resuscitation temperature at admission to Neonatal unit.
Time Frame: Upon admission to Neonatal unit, up to 1 hour after birth
|
For babies admitted to the neonatal unit, the baby's temperature will be measured on admission to the Neonatal unit
|
Upon admission to Neonatal unit, up to 1 hour after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from birth in Apgar score at 5 minutes
Time Frame: upto 5 minutes
|
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.
|
upto 5 minutes
|
Demographic assessments
Time Frame: baseline
|
Researchers will collect both mother's (age, marital status, education, occupation) and baby's demographic characteristics (sex, birth weight, gestation at birth).
|
baseline
|
Design assessments transcripts
Time Frame: uptown 2 months
|
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.
|
uptown 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Andrew D Weeks, MD, University of Liverpool
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BabySaver-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Resuscitation
-
University Hospital PadovaDoctors with Africa - CUAMMCompletedNeonatal ResuscitationEthiopia
-
Columbia UniversityCompletedNeonatal ResuscitationUnited States
-
University of PadovaUnknownNeonatal ResuscitationVietnam
-
St. Justine's HospitalUnknownSimulation | Neonatal Resuscitation
-
IlumensCompleted
-
The University of Texas Health Science Center,...Completed
-
University Hospital PadovaCompletedNeonatal Resuscitation | Heart Rate AssessmentItaly
-
Ahmed MoussaRecruiting
-
University of LahoreCompletedNursing Students Education on Neonatal ResuscitationPakistan