Birth AsphyxiaBabySaverNCT03885492
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
An observational study of Birth Asphyxia and Neonatal Resuscitation, run by Sanyu Africa Research Institute at 1 site in Uganda.
Trial summary
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Asphyxia, Neonatal Resuscitation, Maternal Distress
- How many people
- 47 participants
- Where
- 1 siteUganda
- Study dates
- 1 Nov 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- High risk deliveries will be excluded, namely
- babies born before 34 weeks' gestation,
- babies with life threatening malformations or significant intrapartum asphyxia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
Read the 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.
- Conditions
- Birth Asphyxia, Neonatal Resuscitation, Maternal Distress
- Medical subject headings
- Asphyxia Neonatorum
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Upon admission to Neonatal unit, up to 1 hour after birth
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: uptown 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Nov 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanyu Africa Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Grand Challenges Canada, Mbale Regional Referral Hospital, Makerere University
- Responsible party
- Sponsor
- Investigators
- Andrew D Weeks, MD, Study chair, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885492
- Sponsor's protocol ID
- BabySaver-01
- Acronym
- BabySaver
- Status last verified
- Oct 2023
- First submitted
- 16 Mar 2019
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
- ClinicalTrials.gov ID
- NCT03885492
- Acronym / sponsor ID
- BabySaver / BabySaver-01
- Conditions
- Birth Asphyxia, Neonatal Resuscitation, Maternal Distress
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sanyu Africa Research InstituteUniversity, hospital or other
- Collaborators
- University of Liverpool, Grand Challenges Canada, Mbale Regional Referral Hospital, Makerere University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- High risk deliveries will be excluded, namely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
3 secondary outcomes
change from birth in Apgar score at 5 minutes
Time frame: upto 5 minutes
Demographic assessments
Time frame: baseline
Design assessments transcripts
Time frame: uptown 2 months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Weeks, MD study chair
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Asphyxia and Neonatal Resuscitation, run by Sanyu Africa Research Institute at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from 10 minutes in post-resuscitation temperature at 30 minutes (time frame: Between 10 and 30 minutes after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.