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Trial record 2 of 2 for:    00001973

Understanding Neonatal Jaundice in Rwanda

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ClinicalTrials.gov Identifier: NCT03184948
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
Rwanda Pediatric Association
Rwanda Ministry of Health
Rwanda Bio-Medical Center
Child Relief International
D-Rev
Information provided by (Responsible Party):
Ketki Sheth, 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.

Condition or disease Intervention/treatment Phase
Jaundice, Neonatal Device: Brilliance Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Understanding Neonatal Jaundice in Rwanda
Actual Study Start Date : May 29, 2017
Actual Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Phase 1

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.

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.

Active Comparator: Phase 2

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.

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.

No Intervention: Phase 3

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.




Primary Outcome Measures :
  1. Length of treatment for infant jaundice [ Time Frame: 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.

  2. Length of hospital duration for infant jaundice [ Time Frame: 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 :
  1. Increased rate of reduction in bilirubin [ Time Frame: 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.

  2. Improved Treatment of Jaundice [ Time Frame: 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).

  3. Improved Treatment of Jaundice By Not Being Referred Elsewhere [ Time Frame: 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).

  4. Improved Treatment of Jaundice by Receiving Phototherapy [ Time Frame: Through study completion, an average of 9 months ]
    An indicator variable for whether the patient received phototherapy.

  5. Improved Treatment of Jaundice by Not Sharing Phototherapy [ Time Frame: Through study completion, an average of 9 months ]
    An indicator variable for whether the patient did not share a phototherapy machine with another infant

  6. Improved Treatment of Jaundice by Using Single Phototherapy Device [ Time Frame: Through study completion, an average of 9 months ]
    An indicator variable for whether the patient used multiple phototherapy machines;

  7. Improved Treatment of Jaundice by Reducing Exchange Transfusions [ Time Frame: Through study completion, an average of 9 months ]
    An indicator variable for whether the patient received an exchange transfusion

  8. Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion [ Time Frame: Through study completion, an average of 9 months ]
    An indicator variable for whether the patient reached the threshold for exchange transfusion


Other Outcome Measures:
  1. Age at time of jaundice diagnosis [ Time Frame: Through study completion, an average of 9 months ]
    Average age of infant at the time of jaundice diagnosis

  2. Jaundice diagnosis rates [ Time Frame: Through study completion, an average of 9 months ]
    Rate of infant jaundice diagnoses per month per admitted infants as reported by hospital facility

  3. Jaundice diagnosis levels [ Time Frame: Through study completion, an average of 9 months ]
    Number of infant jaundice diagnoses per month as reported by the hospital facility

  4. Fee Charged [ Time Frame: Through study completion, an average of 9 months ]
    Reduction in cost of jaundice case (fee charged and amount earned by facility per diagnosed jaundice patient) as reported by hospital facility.

  5. Increased technical capacity by Number of Phototherapy Devices [ Time Frame: Through study completion, an average of 9 months ]
    Number of Phototherapy machines at facility

  6. Increased technical capacity by Number of Operational Phototherapy Devices [ Time Frame: Through study completion, an average of 9 months ]
    Number of operational phototherapy machines at facility

  7. Increased technical capacity by Improved Irradiance Levels [ Time Frame: Through study completion, an average of 9 months ]
    Average irradiance levels of phototherapy machines at the hospital facility



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184948


Locations
Rwanda
University Central Hospital of Kigali
Kigali, Rwanda
Sponsors and Collaborators
University of California, Merced
Rwanda Pediatric Association
Rwanda Ministry of Health
Rwanda Bio-Medical Center
Child Relief International
D-Rev
Investigators
Principal Investigator: Ketki Sheth, PhD University of California, Merced
Principal Investigator: Lisine Tuysenge, MD Rwanda Pediatric Association

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site

Responsible Party: Ketki Sheth, Assistant Professor, University of California, Merced
ClinicalTrials.gov Identifier: NCT03184948     History of Changes
Other Study ID Numbers: FWA Assurance No: 00001973
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All IPD collected will be anonymized and aggregated for analysis. The anonymized information will be shared publicly if permission from the Rwandan Ministry of Health is granted.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases