Hypothermia Prevention in Low Birthweight and Preterm Infants

NCT04364204 | Unknown

• 1 other identifier: Pro00095600
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 6

Brief Summary

Preterm birth complications are the leading cause of neonatal mortality and account for over one million neonatal deaths annually. About 12% of babies are born before 37 weeks of gestation, and are at risk for hypothermia, hypoglycemia, infections, and mortality during the first 28 days of life. Kangaroo Mother Care (KMC) has been shown to reduce hypothermia, neonatal infections and neonatal mortality, while improving weight gain and mother-infant attachment; however, implementation to scale has been slow. The BEMPU® bracelet offers the opportunity to monitor the body temperature of newborns for the early detection of hypothermia and to increase the uptake of KMC. Further research is needed to evaluate the impact of the BEMPU® bracelet on KMC practices and neonatal health outcomes and facilitate its adoption in low-resource settings. The goal of this research is to evaluate its effect on KMC practices and neonatal health outcomes in Ghana. Evidence of a significant impact on outcomes will provide critical evidence to facilitate prompt identification of hypothermia, maximize the benefits of KMC, decrease the risk of neonatal death, and impact the leading cause of neonatal mortality in Ghana and other settings.

Conditions

Neonatal Hypothermia

Keywords

newborn; low birthweight; kangaroo mother care

Outcome Measures

Primary Outcomes (1)

• Hypothermia

  Axilliary temperature \<36.5 degrees Celsius assessed at 7 days

  up to 28 days

Secondary Outcomes (4)

• Weight gain

  7 days and 28 days

• Kangaroo Mother Care

  7 days and 28 days

• All cause mortality

  28 days

• Exclusive breastfeeding

  7 days and 28 days

Study Arms (2)

Kangaroo mother care with bracelet

EXPERIMENTAL

Other: Kangaroo Mother Care and BEMPU bracelet

Kangaroo mother care

ACTIVE COMPARATOR

Other: Kangaroo Mother Care

Interventions

Kangaroo Mother Care and BEMPU bracelet OTHER

Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. The BEMPU bracelet, also known as the BEMPU Tempwatch, is a silicone band with a thermistor metal cup that emits an audio alarm and flashes an orange light when the body temperature drops below 36.5⁰C, signaling hypothermia and prompting caregiver to provide thermal care.

Kangaroo mother care with bracelet

Kangaroo Mother Care OTHER

Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. This is the current standard of care for low birthweight/preterm infants.

Kangaroo mother care

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Currently being treated in the KMC or neonatal ward at one of the participating hospitals
• Age\<28 days
• Weight \<2,500 grams at birth
• Clinically stable
• Mother is available, willing and able to provide consent

You may not qualify if:

• Clinically unstable
• Twin or multiple birth
• Ineligible to initiate KMC
• Mother \<18 years of age
• Residence outside health facility catchment area or intention to relocate during the four weeks following discharge

Sponsors & Collaborators

• University of South Carolina: lead
• Centre for Learning and Childhood Development - Ghana: collaborator
• Ghana Health Services: collaborator
• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator

Study Sites (6)

Achimota General Hospital

Accra, Ghana

Location

Greater Accra Regional Hospital

Accra, Ghana

Location

Korle-Bu Teaching Hospital

Accra, Ghana

Location

Princess Marie Luis Children's Hospital

Accra, Ghana

Location

Central Regional Hospital

Cape Coast, Ghana

Location

Eastern Regional Hospital

Koforidua, Ghana

Location

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mufaro Kanyangarara

  University of South Carolina

  PRINCIPAL INVESTIGATOR

• Prince Owusu

  Centre for Learning and Childhood Development - Ghana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mufaro Kanyangarara

CONTACT

8037777562; mufaro@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: April 28, 2020
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GH (6)