Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03599258
Other study ID # Skylife-2018-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date July 15, 2020

Study information

Verified date May 2021
Source HonorHealth Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phototherapy has served as a primary treatment for hyperbilirubinemia in newborn populations. The light emitted through phototherapy interacts with bilirubin at the skin level to transform it into water-soluble products eliminated in urine and stool. Efficacy of phototherapy relies on the irradiance dispensed at the skin level by the treatment and on the surface area of skin exposed. The purpose of this Investigator-initiated, prospective, two-arm, randomized control investigation is to compare the effect of a novel, newly available, FDA cleared, phototherapy device (Neolight Skylife) with the standard phototherapy treatments used in HonorHealth newborn nurseries (Natus-Neo Blue Blanket and GE Bili Soft Blanket) on healthy, newborns ≥ 35 weeks + 0 days Gestational Age (GA) at the time of birth in the treatment of hyperbilirubinemia. We hypothesize that the unconjugated bilirubin level will be comparably reduced across each treatment arm from baseline to 12 and 24 hour intervals.


Description:

This is an investigator-initiated, prospective, two-arm randomized control investigation to examine the mean values in patients' unconjugated bilirubin level for a new, FDA cleared device (Neolight Skylife) with the standard phototherapy treatment. Patient data on unconjugated bilirubin level, pressure ulcer and body temperature will be evaluated at baseline, 12-hours post-intervention, 24 hours post-intervention and at discharge. Neolight Skylife is a compact device that offers phototherapy to infants across all neonatal beds, supplanting multiple, enclosure specific phototherapy devices. Neolight Skylife weighs less than 10 lbs. and is ergonomically designed for portability that allows for easy carrying of the device between beds. Neolight Skylife offers the choice between treatment intensity levels. Neolight Skylife utilizes blue Light-Emitting Diodes (LEDs) to achieve low irradiance of 30 plus or minus 5 μw/cm²/nm, and high irradiance of 45 plus or minus 10, μw/cm²/nm. Neolight Skylife emits light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for treatment. Neolight Skylife eliminates the risk of UV exposure typically seen with phototherapy treatment through the use of blue LEDs, as this light source does not emit significant energy in the ultraviolet (UV) spectrum. However, as with all phototherapy treatment, protective eye coverings are used to protect the baby's eyes from excessive light exposure.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Minutes
Eligibility Inclusion Criteria: 1. Provision of at least one parent/legal guardian's signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Infants born after 35 weeks and 0 days of gestation 4. Infants who developed significant hyperbilirubinemia Infants who developed significant hyperbilirubinemia per BiliToolTM plot requiring phototherapy as determined by the attending neonatologist utilizing the American Academy of Pediatrics' 1. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (Bhutani Nomogram) 2. Guidelines for Phototherapy in Hospitalized Infants of 35 or More Weeks Gestation Exclusion Criteria: Participants will be screened on the following exclusion criteria at the time of enrollment: - Perinatal asphyxia (Apgar score <4 at 1 minute or <7 at 5 minutes) - Respiratory distress - Exchange transfusion - Major congenital malformations As identified throughout the course of the investigation, additional exclusion criteria include: - Direct-reacting component of bilirubin >2 mg/dL - Glucose-6-phosphate deficiency - ABO incompatibility - Evidence of hemolysis - Evidence of sepsis - Rhesus hemolytic disease - Pyruvate kinase deficiency - Severe dehydration

Study Design


Intervention

Device:
Skylife
Newly FDA approved device
Standard Therapy
Both devices are considered standard therapy

Locations

Country Name City State
United States HonorHealth Scottsdale Osborn Medical Center Scottsdale Arizona
United States HonorHealth Scottsdale Shea Medical Center Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
HonorHealth Research Institute Neolight

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in unconjugated bilirubin level from pre-test to post-test heel stick blood draw for unconjugated bilirubin level Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Secondary Maintain body temperature between 97.3F and 99.3F monitor body temperature using a temperature monitoring device Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
Secondary Absence of skin irritation or ulceration visual assessment of the skin for changes Assessment of the endpoint will occur at baseline, 12 hours following treatment, and 24 hours following initial treatment or prior to discharge.
See also
  Status Clinical Trial Phase
Completed NCT00735319 - Transcutaneous Bilirubinometers in the Community N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Withdrawn NCT04021927 - Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy N/A
Completed NCT01887327 - Stannsoporfin With Light Therapy for Newborn Babies With Jaundice Phase 2
Completed NCT04632888 - The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy N/A
Not yet recruiting NCT04527536 - Research of Diagnostic Value for BMJ Infants
Suspended NCT03741803 - Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice N/A
Completed NCT05650463 - Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns N/A
Terminated NCT05623566 - Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia N/A
Completed NCT02612727 - Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates N/A
Completed NCT01434810 - Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates N/A
Completed NCT03184948 - Understanding Neonatal Jaundice in Rwanda N/A
Completed NCT03942757 - BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed NCT06372093 - Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Completed NCT03570775 - Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice N/A
Completed NCT03569254 - Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice N/A
Completed NCT05625880 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Not yet recruiting NCT06449508 - The Effectiveness of Probiotics in Neonatal Jaundice Phase 1/Phase 2