The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda (BabySaver)
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|ClinicalTrials.gov Identifier: NCT03885492|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : May 21, 2020
|Condition or disease|
|Birth Asphyxia Neonatal Resuscitation Maternal Distress|
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 :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
- 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
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885492
|Contact: James Ditai, PhDemail@example.com|
|Contact: Andrew Weeks, MD, MRCOGfirstname.lastname@example.org|
|Principal Investigator:||James Ditai, PhD||Sanyu Africa Research Institute/ University of Liverpool|
|Study Chair:||Andrew Weeks, MD, MRCOG||University of Liverpool, Member of Liverpool health partners, Liverpool, United Kingdom|
|Study Chair:||Anthony Mbonye, PhD||Makerere University|