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

Sanyu Africa Research Institute

Status: Terminated

Conditions: Maternal Distress; Birth Asphyxia; Neonatal Resuscitation

Study type: Observational

Funder types: Other

Identifiers

NCT03885492

BabySaver-01

Details and patient eligibility

About

To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa

Full 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.

Enrollment: 47 patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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