Understanding Neonatal Jaundice in Rwanda

University of California, Merced

Status: Completed

Conditions: Jaundice, Neonatal

Treatments: Device: Brilliance

Study type: Interventional

Funder types: Other

Identifiers

NCT03184948

FWA Assurance No: 00001973

Details and patient eligibility

About

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.

Full description

The Ministry of Health (MIH) in Rwanda has planned to provide Brilliance devices (phototherapy) to 46 public hospitals in Rwanda. The investigators have worked with MIH to have the delivery of these machines be staggered over three phases through random selection. The methodology relies on the staggered distribution of Brilliance devices and survey data collected prior and during delivery dates to evaluate the provision of low-cost high quality phototherapy machines, following the basic design of a staggered randomized controlled trial. Specifically, the investigators will survey all hospitals prior to the receipt of any Brilliance devices to provide a baseline description of the care received in these facilities. These surveys will collect information on the facility itself, including average infant jaundice caseloads and descriptions of recent cases. The investigators will then randomly select 15 hospitals to receive the Brilliance units. Three months after installation of Brilliance has occurred at these facilities (Group 1), another randomly selected subset of 16 facilities (Group 2) will receive their Brilliance machines. Three months after these installations have been completed, the remaining facilities (Group 3) will receive their Brilliance machines. During this period, there will be ongoing data collection from the hospitals, creating a panel dataset on the jaundice-related caseloads at these facilities. The data collected will be akin to collecting hospital records of patients diagnosed with jaundice, but no identifiable patient information will be collected.

Enrollment: 46 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Phase 1

Active Comparator group

Description:

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.

Treatment:

Device: Brilliance

Phase 2

Active Comparator group

Description:

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.

Treatment:

Device: Brilliance

Phase 3

No Intervention group

Description:

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.