NCT03885492

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Sanyu Africa Research Institute · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Birth Asphyxia
• Neonatal Resuscitation
• Maternal Distress

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-03-21
• Last updated: 2023-10-25

Locations

1 site across 1 country: Uganda