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

NCT02612727 | Completed Results DMC

• 1 other identifier: 1108M03601_Phase 2
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Jaundice, Neonatal

Keywords

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (2)

• 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  For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration.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

Study Arms (2)

Filtered-sunlight phototherapy

EXPERIMENTAL

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

Intensive phototherapy

ACTIVE COMPARATOR

Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.

Device: Intensive phototherapy

Interventions

Filtered-sunlight phototherapy DEVICE

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.

Filtered-sunlight phototherapy

Intensive phototherapy DEVICE

Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.

Intensive phototherapy

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects will be eligible to participate in the study if all of the following conditions exist:
• At time of birth, infant is \> 35 weeks gestation (or ≥ 2.2 kg if gestational age is not available.
• Infant is \< 14 days old at the time of enrollment.
• Infant has an elevated TB defined as at the level recommended for high-risk infants per AAP guidelines or higher.
• Parent or guardian has given consent for the infant to participate.

You may not qualify if:

• Subjects will be excluded from enrollment in the study if any of the following conditions exist:
• Infants with a condition requiring referral for treatment not available at the hospital study site.
• Infants with a life-expectancy of \< 24 hours at screening enrollment.
• Infants requiring oxygen therapy unless that can be provided while under PT.
• Infants clinically dehydrated or sunburned at the time of screening enrollment.
• Infants with a temperature \< 36.0 or \> 37.5 degrees Centigrade that does not return to normothermia within 1 hour.

Sponsors & Collaborators

• University of Minnesota: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Bowen University Teaching Hospital

Ogbomoso, Nigeria

Location

Related Publications (2)

• Olusanya BO, Omololu OM, Osamebor FB, Olufosoye A, Alo T, Olaifa SM, Emokpae AA, Olusanya JO, Mabogunje CA. Filtered-sunlight phototherapy for newborns with moderate-to-severe hyperbilirubinemia: a randomized trial. Pediatr Res. 2025 Jun 28. doi: 10.1038/s41390-025-04207-6. Online ahead of print.

  PMID: 40581699 DERIVED

• Olusanya BO, Emokpae AA, Aina OA, Imam ZO, Olaifa SM, Owolabi OB, Osamebor FB, Olufosoye A, Alo T, Osadolor A Jr, Olusanya JO, Mabogunje CA. Heliotherapy for neonates with severe-to-hazardous hyperbilirubinemia: a randomized controlled, non-inferiority trial. Sci Rep. 2024 Oct 27;14(1):25646. doi: 10.1038/s41598-024-77085-3.

  PMID: 39465350 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tina M. Slusher
• Organization: Minnesota Medical Research Foundation (now Hennepin Healthcare) and University of Minnesota

tslusher@umn.edu

612-624-4586

Study Officials

• Tina M Slusher

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority trial comparing the two methods of phototherapy

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 9, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)