An observational study in Birth Asphyxia, Neonatal Resuscitation and Maternal Distress, sponsored by Sanyu Africa Research Institute. Terminated at 1 site in Uganda. Open to female participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Sanyu Africa Research Institute · Observational
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's enrollment of 47 is below the median of 200 across 27 observational studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Sanyu Africa Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
High risk deliveries will be excluded, namely
Change from 10 minutes in post-resuscitation temperature at 30 minutes
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.
Time frame: Between 10 and 30 minutes after birth
Number of procedures performed to newborns while on the BabySaver kit
The researcher will list any resuscitation procedures or interventions provided to the newborns on the kit.
Time frame: at birth, upto 30 minutes
change from childbirth in post-resuscitation temperature at admission to Neonatal unit.
For babies admitted to the neonatal unit, the baby's temperature will be measured on admission to the Neonatal unit
Time frame: Upon admission to Neonatal unit, up to 1 hour after birth
change from birth in Apgar score at 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.
Time frame: upto 5 minutes
Demographic assessments
Researchers will collect both mother's (age, marital status, education, occupation) and baby's demographic characteristics (sex, birth weight, gestation at birth).
Time frame: baseline
Design assessments transcripts
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.
Time frame: uptown 2 months
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Sanyu Africa Research Institute