Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT03885492
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:
NCT03885492
Study Brief:
Protocol Section:
NCT03885492