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

Birth Asphyxia Clinical Trial

— BabySaver  

Official title:

The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03885492
• Other study ID #: BabySaver-01
• Status: Terminated
• Start date: November 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2023
• Source: Sanyu Africa Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Maternal Distress
• Neonatal Resuscitation

Locations

Country	Name	City	State
Uganda	Mbale Regional Referral hospital	Mbale

Sponsors (5)

Lead Sponsor	Collaborator
Sanyu Africa Research Institute	Grand Challenges Canada, Makerere University, Mbale Regional Referral Hospital, University of Liverpool

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between 10 and 30 minutes after birth
Primary	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.	at birth, upto 30 minutes
Primary	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	Upon admission to Neonatal unit, up to 1 hour after birth
Secondary	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.	upto 5 minutes
Secondary	Demographic assessments	Researchers will collect both mother's (age, marital status, education, occupation) and baby's demographic characteristics (sex, birth weight, gestation at birth).	baseline
Secondary	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.	uptown 2 months