Understanding Neonatal Jaundice in Rwanda
- Conditions
- Jaundice, Neonatal
- Interventions
- Device: Brilliance
- Registration Number
- NCT03184948
- Lead Sponsor
- University of California, Merced
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Phase 2 Brilliance 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. Phase 1 Brilliance 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.
- Primary Outcome Measures
Name Time Method Length of treatment for infant jaundice Through study completion, an average of 9 months 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.
Length of hospital duration for infant jaundice Through study completion, an average of 9 months 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.
- Secondary Outcome Measures
Name Time Method Improved Treatment of Jaundice by Reducing Exchange Transfusions Through study completion, an average of 9 months An indicator variable for whether the patient received an exchange transfusion
Improved Treatment of Jaundice by Receiving Phototherapy Through study completion, an average of 9 months An indicator variable for whether the patient received phototherapy.
Improved Treatment of Jaundice by Using Single Phototherapy Device Through study completion, an average of 9 months An indicator variable for whether the patient used multiple phototherapy machines;
Increased rate of reduction in bilirubin Through study completion, an average of 9 months Using different measures of estimated bilirubin levels for one patient and the age at which those tests were provided, we will estimate the change in bilirubin levels over the change in age (by hours) as the rate of reduction in bilirubin levels. This assumes that age at diagnosis is similar across treatment arms. If this is not the case or if our estimates are not precise, we will use maximum bilirubin levels recorded as a proxy. The analysis is conditional on the subset of infants diagnosed with jaundice.
Improved Treatment of Jaundice Through study completion, an average of 9 months An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment).
Improved Treatment of Jaundice By Not Being Referred Elsewhere Through study completion, an average of 9 months An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment).
Improved Treatment of Jaundice by Not Sharing Phototherapy Through study completion, an average of 9 months An indicator variable for whether the patient did not share a phototherapy machine with another infant
Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion Through study completion, an average of 9 months An indicator variable for whether the patient reached the threshold for exchange transfusion
Trial Locations
- Locations (1)
University Central Hospital of Kigali
🇷🇼Kigali, Rwanda