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

NCT03885492 | Terminated

• 1 other identifier: BabySaver-01
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Birth Asphyxia; Neonatal Resuscitation; Maternal Distress

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• change from birth in Apgar score at 5 minutes

  upto 5 minutes

• Demographic assessments

  baseline

• Design assessments transcripts

  uptown 2 months

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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). These include * Deliveries before 37 weeks of gestation * Deliveries with evidence of fetal distress from fetal monitoring * Instrumental deliveries * Deliveries in which there is a possibility of a life-threatening malformation * Deliveries in which meconium stained liquor has been noted.

You may qualify if:

• 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.

You may not qualify if:

• High risk deliveries will be excluded, namely
• babies born before 34 weeks' gestation,
• babies with life threatening malformations or significant intrapartum asphyxia

Sponsors & Collaborators

• Sanyu Africa Research Institute: lead
• University of Liverpool: collaborator
• Grand Challenges Canada: collaborator
• Mbale Regional Referral Hospital: collaborator
• Makerere University: collaborator

Study Sites (1)

Mbale Regional Referral hospital

Mbale, Uganda

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrew D Weeks, MD

  University of Liverpool

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 21, 2019
• Study Start: November 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

UG (1)