Evidence map›Paper›PMID 24373547›Full record

Trial reportTrials2013

Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial.

Tina M Slusher, Bolajoko O Olusanya, Hendrik J Vreman, Ronald J Wong, Ann M Brearley, Yvonne E Vaucher, David K Stevenson

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01434810 (Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01434810 nacompletednot on this map

Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates

TypeinterventionalSponsorUniversity of MinnesotaRan2011 to 2013Enrolled447ConditionsJaundice, NeonatalArmsFiltered-sunlight phototherapy, Conventional phototherapy
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Observational
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Tina M SlusherCenter for Global Health, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA. tslusher@umn.edu.
Bolajoko O Olusanya
Hendrik J Vreman
Ronald J Wong
Ann M Brearley
Yvonne E Vaucher
David K Stevenson
Stanford Medicine · USUniversity of Minnesota · USCentre for Healthy Start Initiative · NGUniversity of California, San Diego · US

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
NICHD Coooperative Multicenter Neonatal Research NetworkU10HD040461 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI VAUCHER, YVONNE ELEANOR · 2001 to 2015
$2.8M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1TR000114NICHD NIH HHS U10 HD040461
6 · The paper itself

Abstract

backgroundSevere neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT. METHODS/

designThis prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm²/nm. PRIMARY OUTCOME: FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT.

conclusionThis novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics.

trial registrationClinicalTrials.gov Identifier: NCT01434810.

Indexed as

Research DesignSunlightBilirubinBiomarkersClinical ProtocolsDeveloping CountriesHospitals, MaternityHumansInfant, NewbornJaundice, NeonatalNigeriaProspective StudiesTime FactorsTreatment OutcomeUltraviolet TherapyUp-RegulationBilirubinBiomarkers

Identifiers

PMID24373547
PMCPMC3879162
OpenAlexW2170626263

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.