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

NCT01434810 | Completed Results DMC

• 1 other identifier: 1108M03601
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (2)

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  For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration.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

  Four to ten days

• 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).

  Four to ten days

Secondary Outcomes (1)

• Number of Participants Requiring Exchange Blood Transfusion

  Four to ten days

Study Arms (2)

Filtered-sunlight phototherapy

EXPERIMENTAL

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: Filtered-sunlight phototherapy

Conventional phototherapy

ACTIVE COMPARATOR

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

Device: Conventional phototherapy

Interventions

Filtered-sunlight phototherapy DEVICE

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.

Filtered-sunlight phototherapy

Conventional phototherapy DEVICE

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

Conventional 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
• At time of enrollment, infant has an elevated TcB defined as 3 mg/dL below 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 participation in the study if any of the following conditions exist at the time of enrollment:
• Infants with a condition requiring referral for treatment not available at the hospital study site and/or conventional phototherapy unit.
• Infants with a life-expectancy of \< 24 hours
• Infants requiring oxygen therapy
• Infants clinically dehydrated or sunburned
• Infants with a temperature \< 35.5 or \> 38 degrees Centigrade
• Infants with ABE on clinical exam
• Infants meeting the criteria for EBT

Sponsors & Collaborators

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

Study Sites (1)

Island Maternity Hospital

Lagos, Nigeria

Location

Related Publications (2)

• Slusher TM, Olusanya BO, Vreman HJ, Brearley AM, Vaucher YE, Lund TC, Wong RJ, Emokpae AA, Stevenson DK. A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates. N Engl J Med. 2015 Sep 17;373(12):1115-24. doi: 10.1056/NEJMoa1501074.

  PMID: 26376136 DERIVED

• Slusher TM, Olusanya BO, Vreman HJ, Wong RJ, Brearley AM, Vaucher YE, Stevenson DK. Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial. Trials. 2013 Dec 28;14:446. doi: 10.1186/1745-6215-14-446.

  PMID: 24373547 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 and University of Minnesota

tslusher@umn.edu

612-624-4586

Study Officials

• Tina M Slusher, MD

  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
• 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: August 30, 2011
• First Posted: September 15, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)