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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03184948
Other study ID # FWA Assurance No: 00001973
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2017
Est. completion date June 1, 2018

Study information

Verified date March 2020
Source University of California, Merced
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 46
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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:

-

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Brilliance
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.

Locations

Country Name City State
Rwanda University Central Hospital of Kigali Kigali

Sponsors (6)

Lead Sponsor Collaborator
University of California, Merced Child Relief International, D-Rev, Ministry of Health, Rwanda, Rwanda Bio-Medical Center, Rwanda Pediatric Association

Country where clinical trial is conducted

Rwanda, 

Outcome

Type Measure Description Time frame Safety issue
Other Age at time of jaundice diagnosis Average age of infant at the time of jaundice diagnosis Through study completion, an average of 9 months
Other Jaundice diagnosis rates Rate of infant jaundice diagnoses per month per admitted infants as reported by hospital facility Through study completion, an average of 9 months
Other Jaundice diagnosis levels Number of infant jaundice diagnoses per month as reported by the hospital facility Through study completion, an average of 9 months
Other Fee Charged Reduction in cost of jaundice case (fee charged and amount earned by facility per diagnosed jaundice patient) as reported by hospital facility. Through study completion, an average of 9 months
Other Increased technical capacity by Number of Phototherapy Devices Number of Phototherapy machines at facility Through study completion, an average of 9 months
Other Increased technical capacity by Number of Operational Phototherapy Devices Number of operational phototherapy machines at facility Through study completion, an average of 9 months
Other Increased technical capacity by Improved Irradiance Levels Average irradiance levels of phototherapy machines at the hospital facility Through study completion, an average of 9 months
Primary 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
Primary 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 Increased rate of reduction in bilirubin 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. Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment). Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice By Not Being Referred Elsewhere An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment). Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice by Receiving Phototherapy An indicator variable for whether the patient received phototherapy. Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice by Not Sharing Phototherapy An indicator variable for whether the patient did not share a phototherapy machine with another infant Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice by Using Single Phototherapy Device An indicator variable for whether the patient used multiple phototherapy machines; Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice by Reducing Exchange Transfusions An indicator variable for whether the patient received an exchange transfusion Through study completion, an average of 9 months
Secondary Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion An indicator variable for whether the patient reached the threshold for exchange transfusion Through study completion, an average of 9 months
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