Jaundice, Neonatal Clinical Trial
Official title:
Understanding Neonatal Jaundice in Rwanda
Verified date | March 2020 |
Source | University of California, Merced |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
Rwanda | University Central Hospital of Kigali | Kigali |
Lead Sponsor | Collaborator |
---|---|
University of California, Merced | Child Relief International, D-Rev, Ministry of Health, Rwanda, Rwanda Bio-Medical Center, Rwanda Pediatric Association |
Rwanda,
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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