Skip to main content
OpenTrials
Completed

NCT Number: NCT03184948

Understanding Neonatal Jaundice in Rwanda

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Jaundice, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Central Hospital of Kigali

Kigali, Rwanda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Brilliance

Device

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Merced

Other

Collaborators

  • Child Relief International
  • D-Rev
  • Ministry of Health, Rwanda
  • Rwanda Bio-Medical Center
  • Rwanda Pediatric Association

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2017
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.