Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates (FSPT)

At present, much of sub-Saharan Africa, including Nigeria and other resource-limited countries, are without ready access to CPT, due to factors including the lack of PT devices, which are expensive and require consistent electric power to operate. NHB is a significant cause of neonatal morbidity and mortality, but preventable when appropriate treatment is initiated. We have shown that FS-PT is safe and efficacious for the treatment of mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but more specially as defined as needing phototherapy per American Academy of Pediatric 2004 guidelines). This arm was done at 1 site in Nigeria (in Ogbomoso). The rationale for conducting the study is that in Nigeria, and other countries that cannot afford effective commercial light devices and/or have no reliable electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice.

Study Overview

• Status: Completed
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Device: Filtered-sunlight phototherapy; Device: Intensive phototherapy

Detailed Description

Severe neonatal hyperbilirubinemia (NHB) and its progression to kernicterus is a leading cause of deaths and disabilities among newborns in the developing world, particularly in sub-Saharan Africa including Nigeria. Many infants live in villages/towns far from clinical facilities capable of providing conventional artificial blue light phototherapy (CPT) which is the standard treatment for NHB in the industrialized world. Hence, more babies succumb to this preventable tragedy principally on account of lack of electricity and/or available/affordable CPT.

To make treatment of NHB more readily available, we designed and tested a novel, yet simple, practical alternative device to deliver blue light PT in underserved areas from filtered sunlight. The investigators pilot study demonstrated that appropriately filtered sunlight phototherapy (FS-PT) not only offers safe and affordable treatment for infants with mild-moderate NHB, but is also no less efficacious than CPT. Other studies have shown faster decline at higher bilirubin (TB) levels and with higher irradiances. The next logical step to move this urgently needed and exciting therapy forward is to test FS-PT in infants with significant/severe NHB as defined by the American Academy of Pediatrics (AAP) criteria for high-risk infants. In doing so, the investigators will potentially be preventing acute bilirubin encephalopathy (ABE) and kernicterus in many of these infants.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ogbomoso, Nigeria
    • Bowen University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will be eligible to participate in the study if all of the following conditions exist:

  1. At time of birth, infant is > 35 weeks gestation (or ≥ 2.2 kg if gestational age is not available.
  2. Infant is < 14 days old at the time of enrollment.
  3. Infant has an elevated TB defined as at the level recommended for high-risk infants per AAP guidelines or higher.
  4. Parent or guardian has given consent for the infant to participate.

Exclusion Criteria:

• Subjects will be excluded from enrollment in the study if any of the following conditions exist:

  1. Infants with a condition requiring referral for treatment not available at the hospital study site.
  2. Infants with a life-expectancy of < 24 hours at screening enrollment.
  3. Infants requiring oxygen therapy unless that can be provided while under PT.
  4. Infants clinically dehydrated or sunburned at the time of screening enrollment.
  5. Infants with a temperature < 36.0 or > 37.5 degrees Centigrade that does not return to normothermia within 1 hour.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Filtered-sunlight phototherapy; Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.	Device: Filtered-sunlight phototherapy; Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.
Active Comparator: Intensive phototherapy; Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.	Device: Intensive phototherapy; Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Phototherapy	For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if <72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).	2 to 10 days
Safety of Phototherapy	For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration. Therefore safety is reported as a percentage of the total treatment days (i.e. number of safe treatment days divided by total number of treatment days).	2 to 10 days

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Thrasher Research Fund
• Investigators: Principal Investigator: Tina M Slusher, University of Minnesota

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Hyperbilirubinemia, Neonatal
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: 1108M03601_Phase 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No