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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01434810
First received: August 30, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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. We have completed Phase I of the study and it was safe and efficacious. We are ready to begin the non-inferiority RCT Phase II of the study comparing sunlight phototherapy with conventional phototherapy


Condition Intervention Phase
Jaundice, Neonatal
Procedure: Window tinting film for filtered sunlight phototherapy
Device: conventional phototherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in Serum Bilirubin [ Time Frame: Serum bilirubin will be measured daily during sunlight phototherapy exposure (for an expected average of four days, and a maximum of ten days). ] [ Designated as safety issue: Yes ]
    Diminished rate of total serum bilirubin for infants less than or equal to 72 hours old and a decline of total serum bilirubin in infants greater than 72 hour old.

  • Incidence of Sunburn and Dehydration [ Time Frame: Infants will be monitored hourly for sunburn and dehydration during the duration of sunlight phototherapy exposure (for an expected average of four days and a maximum of ten days). ] [ Designated as safety issue: Yes ]
    Ability to tolerate at least 6 hours of sunlight phototherapy per day while maintaining normothermia (axillary temperature of 36.5-37.5 degrees Centigrade) without significant dehydration or sunburn.

  • Non-inferiority of sunlight phototherapy [ Time Frame: Serum bilirubin will be measured twice daily in both infants receiving sunlight and conventional phototherapy ] [ Designated as safety issue: Yes ]
    We wish to demonstrate that the efficacy of sunlight PT is not worse than that of conventional PT (non-inferiority study)


Secondary Outcome Measures:
  • Number of participants requiring intervention such as exchange blood transfusion [ Time Frame: Data will be recorded daily during sunlight phototherapy exposure (for an expected average of four days and a maximum of ten days). ] [ Designated as safety issue: Yes ]
    Intervention, such as exchange blood transfusion, required to lower the bilirubin level.


Estimated Enrollment: 616
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Filtered sunlight phototherapy
Window tinting film
Procedure: Window tinting film for filtered sunlight phototherapy
Six hours of filtered sunlight phototherapy for 1 to 10 days.
Other Name: Windown tinting films by Solutia, Inc., and V-KOOL, Inc.
Active Comparator: Conventional phototherapy
Infants will be randomized to conventional phototherapy (new arm)
Device: conventional phototherapy
conventional phototherapy unit will be used for infants randomized to this arm for1-10 days

Detailed Description:

Numerous studies from resource-limited countries suggest that severe neonatal jaundice (NNJ) represents the largest unrecognized cause of neonatal morbidity and mortality in the world. Several studies from Africa rank jaundice as a leading cause of death in newborn nurseries. In Nigeria, Owa and Osinaike reported that jaundice (14%) was the second leading cause of death, while Ugwu et al, found that mortality from severe jaundice was comparable to birth asphyxia but greater than sepsis in neonates >24 hrs old to 7 days old. In Kenya, English et al reported NNJ as the third leading cause of both newborn admissions and deaths. Studies from Nigeria, Zimbabwe, Turkey, North Vietnam, Oman, and India listed acute bilirubin encephalopathy (ABE) and/or severe NNJ as a significant cause of morbidity, many of whom required exchange blood transfusion (EBT) in their nurseries. Unfortunately, phototherapy, as important as it is, may not be available to many infants with NNJ in these countries because of the lack of devices and/or of unreliable electrical power supply. Commercial phototherapy (PT) devices are expensive, often break down due to surges in electrical power, and are difficult to maintain due to unavailability of spare parts. Even where PT devices are available, most hospitals in these countries lack the resources to replace the fluorescent light bulbs at the recommended 2000-3000 hrs of use and simply leave ineffective tubes in place until they burn out. Moreover, very few hospitals have appropriate irradiance meters for monitoring the intensity of the blue light emitted by the lamps. In a recent study in Nigeria by Owa et al, none of the tested PT devices provided the level of irradiance required for intensive PT.

Often, the only treatment a healthcare provider can suggest to the parents/guardians of jaundiced infants is to place their babies in sunlight. However, this practice is unsuitable due to several safety concerns. For instance, exposure to ultraviolet (UV) light may cause sunburn, while infrared (IR) light may cause the body to overheat. Moreover, the infant may lose body heat from the uncovered skin during treatment, with potential for dehydration. A safer, yet practical and economical, solution is needed, providing the basis for our proposal of filtered sunlight PT.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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. 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
  4. Parent or guardian has given consent for the infant to participate

Exclusion Criteria:

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

  1. Infants with a condition requiring referral for treatment not available at the hospital study site and/or conventional phototherapy unit.
  2. Infants with a life-expectancy of < 24 hours
  3. Infants requiring oxygen therapy
  4. Infants clinically dehydrated or sunburned
  5. Infants with a temperature < 35.5 or > 38 degrees Centigrade
  6. Infants with ABE on clinical exam
  7. Infants meeting the criteria for EBT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434810

Contacts
Contact: Tina M Slusher, M.D. 612-840-8843 tinamslusher@gmail.com

Locations
Nigeria
Island Maternity Hospital Recruiting
Lagos, Nigeria
Contact: Bolajoko O Olusanya, MBBS    0112348033344300    BOOLUSANYA@aol.com   
Principal Investigator: Bolajoko O Olusanya, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Thrasher Research Fund
Investigators
Principal Investigator: Tina M Slusher, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01434810     History of Changes
Other Study ID Numbers: 1108M03601
Study First Received: August 30, 2011
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Hyperbilirubinemia, Neonatal

Additional relevant MeSH terms:
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 28, 2014