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

NCT01434810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2019-02-05

Study results available
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Summary

The primary objective of this study is to determine the safety and efficacy of filtered sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The rationale for conducting the study is that in Nigeria, and other countries that may not have effective commercial light devices or have reliable access to electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical trial comparing the efficacy of filtered sunlight phototherapy with conventional phototherapy.

Conditions

  • Jaundice, Neonatal

Interventions

DEVICE

Filtered-sunlight phototherapy

Infants will receive six hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using window tinting film. Window tinting films by Solutia, Inc., and V-KOOL, Inc.

DEVICE

Conventional phototherapy

Infants will receive six hours per day of conventional phototherapy for 1 to 10 days.

Sponsors & Collaborators

Principal Investigators

  • Tina M Slusher, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Nigeria

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434810 on ClinicalTrials.gov