Jaundice, NeonatalNCT03184948
Understanding Neonatal Jaundice in Rwanda
A study testing Brilliance in people with Jaundice, Neonatal, run by University of California, Merced at 1 site in Rwanda.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Brilliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteRwanda
- Study dates
- 29 May 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Jaundice, Neonatal
- Being tested
- Brilliance
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrillianceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Active comparator | 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. Receives: Device: Brilliance |
| Phase 2 | Active comparator | 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. Receives: Device: Brilliance |
| Phase 3 | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 9 months
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.
Measured: Through study completion, an average of 9 months
Secondary outcomes (8)
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.
Measured: Through study completion, an average of 9 months
Improved Treatment of Jaundice
An indicator variable for whether the patient was treated at the facility (as opposed to being referred elsewhere for treatment).
Measured: Through study completion, an average of 9 months
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).
Measured: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Receiving Phototherapy
An indicator variable for whether the patient received phototherapy.
Measured: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Sharing Phototherapy
An indicator variable for whether the patient did not share a phototherapy machine with another infant
Measured: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Using Single Phototherapy Device
An indicator variable for whether the patient used multiple phototherapy machines;
Measured: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Reducing Exchange Transfusions
An indicator variable for whether the patient received an exchange transfusion
Measured: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion
An indicator variable for whether the patient reached the threshold for exchange transfusion
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start29 May 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Merced
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Pediatric Association, Ministry of Health, Rwanda, Rwanda Bio-Medical Center, Child Relief International, D-Rev
- Responsible party
- Principal investigator, Ketki Sheth, University of California, Merced
- Investigators
- Ketki Sheth, PhD, Principal investigator, University of California, MercedLisine Tuysenge, MD, Principal investigator, Rwanda Pediatric Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184948
- Sponsor's protocol ID
- FWA Assurance No: 00001973
- Status last verified
- Mar 2020
- First submitted
- 5 Jun 2017
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Neonatal Jaundice in Rwanda
- ClinicalTrials.gov ID
- NCT03184948
- Acronym / sponsor ID
- FWA Assurance No: 00001973
- Conditions
- Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Collaborators
- Rwanda Pediatric Association, Ministry of Health, Rwanda, Rwanda Bio-Medical Center, Child Relief International, D-Rev
- Study start
- 29 May 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Active comparator | Device: BrillianceThis 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. |
| Phase 2 | Active comparator | Device: BrillianceThis 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 3 | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrillianceThe 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. | Device | Phase 1, Phase 2 |
Primary outcome
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.
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.
8 secondary outcomes
Increased rate of reduction in bilirubin
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice By Not Being Referred Elsewhere
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Receiving Phototherapy
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Sharing Phototherapy
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Using Single Phototherapy Device
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Reducing Exchange Transfusions
Time frame: Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion
Time frame: Through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketki Sheth, PhD principal investigator
University of California, Merced
Lisine Tuysenge, MD principal investigator
Rwanda Pediatric Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brilliance in people with Jaundice, Neonatal, run by University of California, Merced at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of treatment for infant jaundice (time frame: Through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.