Understanding Neonatal Jaundice in Rwanda

NCT03184948 | Completed

• 1 other identifier: FWA Assurance No: 00001973
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study exploits the distribution of low-cost high-quality phototherapy devices (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of improved technology improves health care for infant jaundice. Specifically, the investigators are interested in measuring whether the provision of an additional high-quality phototherapy device, a known effective treatment for jaundice, successfully translates into improved care of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (2)

• Length of treatment for infant jaundice

  Number of hours infant diagnosed with jaundice is provided phototherapy (PT). This is calculated by subtracting the age at which the patient is first given PT from the age at which the patient is removed from PT. The analysis is conditional on the subset of infants diagnosed with jaundice.

  Through study completion, an average of 9 months

• Length of hospital duration for infant jaundice

  This is measured by the duration of stay at the facility, as measured by the time between being admitted and being discharged. The analysis is conditional on the subset of infants diagnosed with jaundice.

  Through study completion, an average of 9 months

Secondary Outcomes (8)

• Increased rate of reduction in bilirubin

  Through study completion, an average of 9 months

• Improved Treatment of Jaundice

  Through study completion, an average of 9 months

• Improved Treatment of Jaundice By Not Being Referred Elsewhere

  Through study completion, an average of 9 months

• Improved Treatment of Jaundice by Receiving Phototherapy

  Through study completion, an average of 9 months

• Improved Treatment of Jaundice by Not Sharing Phototherapy

  Through study completion, an average of 9 months

Other Outcomes (7)

• Age at time of jaundice diagnosis

  Through study completion, an average of 9 months

• Jaundice diagnosis rates

  Through study completion, an average of 9 months

• Jaundice diagnosis levels

  Through study completion, an average of 9 months

Study Arms (3)

Phase 1

ACTIVE COMPARATOR

This is the first set of randomly selected hospitals to receive the intervention (Brilliance device). The intervention to be provided is the phototherapy device, Brilliance. \*No individual participants are recruited for this study.

Device: Brilliance

Phase 2

ACTIVE COMPARATOR

This is the second set of hospitals to receive the device. For the first three months, they receive no intervention, after which they become part of the "active comparator" arm. The intervention to be provided is the phototherapy device, Brilliance. \*No individual participants are recruited for this study.

Device: Brilliance

Phase 3

NO INTERVENTION

This is the last set of hospitals to receive the device. For the first six months, they receive no intervention, after which the study is completed and they are given the device Brilliance. \*No individual participants are recruited for this study.

Interventions

Brilliance DEVICE

The intervention is the provision of the Brilliance phototherapy machines to hospitals. This device is to be provided to facilities regardless of the study -- the study's involvement has been to collaborate with the Ministry of Health so that Brilliance is distributed in a randomized staggered method. In that sense, the study may be considered observational, as the study is not driving whether or not a hospital receives Brilliance, only when it receives Brilliance in a short time frame.

Phase 1; Phase 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For patient level record (de-identified), diagnosed by the facility for having infant jaundice
• The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines.

Sponsors & Collaborators

• University of California, Merced: lead
• Rwanda Pediatric Association: collaborator
• Ministry of Health, Rwanda: collaborator
• Rwanda Bio-Medical Center: collaborator
• Child Relief International: collaborator
• D-Rev: collaborator

Study Sites (1)

University Central Hospital of Kigali

Kigali, Rwanda

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ketki Sheth, PhD

  University of California, Merced

  PRINCIPAL INVESTIGATOR

• Lisine Tuysenge, MD

  Rwanda Pediatric Association

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Hospitals (i.e., participants) receive the intervention (i.e., Brilliance phototherapy device) at different times in the study. In the first phase, a set of hospital facilities receive the device. After three months of using the device, another set of hospital facilities receive the device. And after an additional three months (approximately 6 months after the first set of hospitals implemented their device), all hospitals will have been provided with the intervention.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 14, 2017
• Study Start: May 29, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

RW (1)