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Understanding neonatal jaundice management in Rwanda
Last registered on May 29, 2017

Pre-Trial

Trial Information
General Information
Title
Understanding neonatal jaundice management in Rwanda
RCT ID
AEARCTR-0002246
Initial registration date
May 29, 2017
Last updated
May 29, 2017 6:43 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
UC Merced
Other Primary Investigator(s)
PI Affiliation
Additional Trial Information
Status
In development
Start date
2017-05-29
End date
2018-10-01
Secondary IDs
Abstract
The proposed study will determine the effect that installing affordable, high-quality phototherapy machines (“Brilliance”) at Rwandan public hospitals has on newborn jaundice management outcomes, as measured by reduction in extreme bilirubin levels and other proxies for improved treatment and health. The methodology is a staggered randomized controlled trial, in which 46 hospitals will receive Brilliance machines during one of three installation phases (randomly determined), each three months apart. Baseline information and ongoing information on jaundice cases will be collected based on hospital interviews and records. One hundred six “Brilliance” phototherapy machines and 46 light meters will be installed in total.

Phototherapy is a proven and recommended treatment for newborn with hyperbilirubinemia (jaundice), which remains a persistent and significant contributor to newborn morbidity and mortality. Less is known, however, about how hospitals in settings like Rwanda incorporate high-quality technologies into their treatment protocols, and whether installation and standard device training is enough to significantly improve health outcomes. Therefore, this is not a study on the effectiveness of a phototherapy device at treating jaundice (as this is already known), but rather a study understanding how hospitals incorporate new improved technologies into their medical care, particular in resource-scarce countries. Clearer answers to these questions can guide health care practitioners and policy makers on how to develop effective strategies for incorporating new health technologies to eliminate newborn death and disability due to untreated jaundice.
External Link(s)
Registration Citation
Citation
Sheth, Ketki and Lisine Tuyisenge. 2017. "Understanding neonatal jaundice management in Rwanda." AEA RCT Registry. May 29. https://doi.org/10.1257/rct.2246-1.0.
Former Citation
Sheth, Ketki, Ketki Sheth and Lisine Tuyisenge. 2017. "Understanding neonatal jaundice management in Rwanda." AEA RCT Registry. May 29. http://www.socialscienceregistry.org/trials/2246/history/18108.
Experimental Details
Interventions
Intervention(s)
Hospitals will be provided high-quality and low cost phototherapy devices (Brilliance) to treat infant jaundice.
Intervention Start Date
2017-07-01
Intervention End Date
2018-03-01
Primary Outcomes
Primary Outcomes (end points)
Our primary outcomes of interest is 1) duration of treatment, as measured by length of stay in the hospital and number of hours receiving photo therapy, 2) reduced bilirubin levels, as measured by reduction in peak bilirubin levels and faster reduction in bilirubin levels, and 3) reduction in exchange transfusions, as measured by performing exchange transfusion or reaching the level of an exchange transfusion.

Additional outcomes of interest are 1) improved technological capacity: increased number of phototherapy machines, increased number of operational phototherapy machines, higher average irradiance levels of phototherapy machines; increased likelihood of being treated by phototherapy, reduction in sharing of phototherapy machines by patients, reduction in using multiple phototherapy machines per patient, 2) reduced fees charged to patients, and 3) increased diagnosis of jaundice, as measured by incidence rate and reduction in the average age at time of diagnosis.

We will look at heterogeneity based on patient gender, pre-term, and initial bilirubin level.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Hospitals will be randomly assigned as to one of three phases which determines when the hospital will receive the intervention (phototherapy devices). The duration between phases is estimated to be 3 months after complete installation of machines.
Experimental Design Details
Randomization Method
The randomization will be done in an office by a computer.
Randomization Unit
The unit of randomization are hospitals.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
46 hospitals.
Sample size: planned number of observations
Anonymized patient records of jaundiced infants will be collected from each hospital over a duration of 7 to 12 months. The expected number of observations this will yield is unknown.
Sample size (or number of clusters) by treatment arms
15 hospitals treated in Phase 1, 16 hospitals treated in Phase 2, 15 hospitals treated in Phase 3. We will be using data collected prior to the intervention and during the intervention. Therefore, in Phase 1 of the study, we will have 15 treated hospitals and 31 control hospitals. In Phase 2, we will have 31 treated hospitals and 15 control hospitals. Prior to Phase 1, all hospitals will be "control" hospitals, and after the start of Phase 3, all hospitals will be treated hospitals.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Rwanda National Ethics Committee
IRB Approval Date
2017-04-04
IRB Approval Number
FWA Assurance No. 00001973; IRB 00001497
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS