Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-02 @ 7:44 AM
Study NCT ID:
NCT03885492
Status:
TERMINATED
Last Update Posted:
2023-10-25
First Post:
2019-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
Sponsor:
Sanyu Africa Research Institute
Organization:
Study Overview
Official Title:
The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BabySaver
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: