Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns

Launched by HONORHEALTH RESEARCH INSTITUTE · Jul 23, 2018

Keywords

ClinConnect Summary

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....

Gender

ALL

Eligibility criteria

• 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