Clinical trial NCT03184948: Understanding Neonatal Jaundice in Rwanda
Official title: Understanding Neonatal Jaundice in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: University of California, Merced
Sponsor class: OTHER
Collaborators: name: Rwanda Pediatric Association
name: Ministry of Health, Rwanda
name: Rwanda Bio-Medical Center
name: Child Relief International
name: D-Rev
First posted: 2017-06-14
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Length of treatment for infant jaundice
timeFrame: Through study completion, an average of 9 months
measure: Length of hospital duration for infant jaundice
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Increased rate of reduction in bilirubin
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice By Not Being Referred Elsewhere
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice by Receiving Phototherapy
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice by Not Sharing Phototherapy
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice by Using Single Phototherapy Device
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice by Reducing Exchange Transfusions
timeFrame: Through study completion, an average of 9 months
measure: Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion
timeFrame: Through study completion, an average of 9 months
Other outcomes:
measure: Age at time of jaundice diagnosis
timeFrame: Through study completion, an average of 9 months
measure: Jaundice diagnosis rates
timeFrame: Through study completion, an average of 9 months
measure: Jaundice diagnosis levels
timeFrame: Through study completion, an average of 9 months
measure: Fee Charged
timeFrame: Through study completion, an average of 9 months
measure: Increased technical capacity by Number of Phototherapy Devices
timeFrame: Through study completion, an average of 9 months
measure: Increased technical capacity by Number of Operational Phototherapy Devices
timeFrame: Through study completion, an average of 9 months
measure: Increased technical capacity by Improved Irradiance Levels
timeFrame: Through study completion, an average of 9 months
Locations:
city: Kigali
country: Rwanda
facility: University Central Hospital of Kigali
Study officials:
affiliation: University of California, Merced
name: Ketki Sheth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Pediatric Association
name: Lisine Tuysenge, MD
role: PRINCIPAL_INVESTIGATOR
References: