The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda

Terminated

• Conditions: Neonatal Resuscitation; Birth Asphyxia; Maternal Distress

• Registration Number: NCT03885492
• Lead Sponsor: Sanyu Africa Research Institute

Brief 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

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 Timeline

• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2020-11-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change from childbirth in post-resuscitation temperature at admission to Neonatal unit.	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 10 minutes in post-resuscitation temperature at 30 minutes	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	at birth, upto 30 minutes	The researcher will list any resuscitation procedures or interventions provided to the newborns on the kit.

Secondary Outcome Measures

Name	Time	Method
Design assessments transcripts	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.
change from birth in Apgar score at 5 minutes	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	baseline	Researchers will collect both mother's (age, marital status, education, occupation) and baby's demographic characteristics (sex, birth weight, gestation at birth).

Trial Locations

Locations (1)

Mbale Regional Referral hospital; 🇺🇬 Mbale, Uganda