Unknown statusInterventionalNot ApplicableUpdated Oct 22, 2020
Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With... | NCT03074292 | Trialant
Unknown statusInterventionalNot ApplicableUpdated Mar 8, 2017
Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
ClinicalTrials.gov ID
NCT03074292
Lead Sponsor
Rania Ali El-FarrashOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
120Actual
Last Update Posted
Mar 8, 2017Actual
Start Date
Dec 2013
Primary Completion Date
Mar 2017Estimated
Completion Date
Mar 2017Estimated
Brief Summary
The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.
Oxidative Stress
Neonatal Hyperbilirubinemia
Phototherapy Complication
phototherapy
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
Normal blood counts and peripheral blood smears
Normal reticulocytic count.
Breast fed newborn.
Exclusion Criteria:
Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
Infant of diabetic mothers.
Maternal eclampsia-preeclampsia.
Birth asphyxia
Sepsis
congenital anomalies.
Direct Coombs'test positive
Pathological causes of hyperbilirubinemia.
Enclosed hemorrhage.
Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.