Clinical trial NCT03885492: The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
Official title: The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Birth Asphyxia
Neonatal Resuscitation
Maternal Distress
Lead sponsor: Sanyu Africa Research Institute
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: Grand Challenges Canada
name: Mbale Regional Referral Hospital
name: Makerere University
First posted: 2019-03-21
Enrollment: 47
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from 10 minutes in post-resuscitation temperature at 30 minutes
timeFrame: Between 10 and 30 minutes after birth
measure: Number of procedures performed to newborns while on the BabySaver kit
timeFrame: at birth, upto 30 minutes
measure: change from childbirth in post-resuscitation temperature at admission to Neonatal unit.
timeFrame: Upon admission to Neonatal unit, up to 1 hour after birth
Secondary outcomes:
measure: change from birth in Apgar score at 5 minutes
timeFrame: upto 5 minutes
measure: Demographic assessments
timeFrame: baseline
measure: Design assessments transcripts
timeFrame: uptown 2 months
Other outcomes:
Locations:
city: Mbale
country: Uganda
facility: Mbale Regional Referral hospital
Study officials:
affiliation: University of Liverpool
name: Andrew D Weeks, MD
role: STUDY_CHAIR
References: