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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885492
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : May 21, 2020
Sponsor:
Collaborators:
University of Liverpool
Grand Challenges Canada
Mbale Regional Referral Hospital
Makerere University
Information provided by (Responsible Party):
Sanyu Africa Research Institute

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

Condition or disease
Birth Asphyxia Neonatal Resuscitation Maternal Distress

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Baby-Saver Kit: Development and Evaluation of a Novel Device for Affordable Neonatal Resuscitation in a Low-income Region in Africa
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from 10 minutes in post-resuscitation temperature at 30 minutes [ Time Frame: Between 10 and 30 minutes after birth ]
    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.

  2. Number of procedures performed to newborns while on the BabySaver kit [ Time Frame: at birth, upto 30 minutes ]
    The researcher will list any resuscitation procedures or interventions provided to the newborns on the kit.

  3. change from childbirth in post-resuscitation temperature at admission to Neonatal unit. [ Time Frame: Upon admission to Neonatal unit, up to 1 hour after birth ]
    For babies admitted to the neonatal unit, the baby's temperature will be measured on admission to the Neonatal unit


Secondary Outcome Measures :
  1. change from birth in Apgar score at 5 minutes [ Time Frame: upto 5 minutes ]
    Apgar score will be recorded at 1 minute and 5 minutes. Resuscitation of babies at birth will be performed in line with existing hospital guidelines.

  2. Demographic assessments [ Time Frame: baseline ]
    Researchers will collect both mother's (age, marital status, education, occupation) and baby's demographic characteristics (sex, birth weight, gestation at birth).

  3. Design assessments transcripts [ Time Frame: uptown 2 months ]
    Researchers will collect data about design and practical aspects of the BabySaver kit from mothers, carers, midwives and doctors in form of audio and video recordings and extra notes. These will be transcribed verbatim for analysis using an NVivo qualitative software.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885492


Contacts
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Contact: James Ditai, PhD 256782620193 j.ditai@safri.ac.ug
Contact: Andrew Weeks, MD, MRCOG +447922156842 aweeks@liv.ac.uk

Locations
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Uganda
Mbale Regional Referral hospital
Mbale, Uganda
Contact: Kathy Burgoine, MBBS    +256778236572    kathy.burgoine@gmail.com   
Contact: Julian Abeso, MMED (Paed)    +256712834767    jabeso_2004@yahoo.com   
Sub-Investigator: Kathy Burgoine, MBBS         
Sponsors and Collaborators
Sanyu Africa Research Institute
University of Liverpool
Grand Challenges Canada
Mbale Regional Referral Hospital
Makerere University
Investigators
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Principal Investigator: James Ditai, PhD Sanyu Africa Research Institute/ University of Liverpool
Study Chair: Andrew Weeks, MD, MRCOG University of Liverpool, Member of Liverpool health partners, Liverpool, United Kingdom
Study Chair: Anthony Mbonye, PhD Makerere University
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Responsible Party: Sanyu Africa Research Institute
ClinicalTrials.gov Identifier: NCT03885492    
Other Study ID Numbers: BabySaver-01
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases