Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 14 days
Healthy Volunteers: t
View:
⁃ Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:
• positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
• HGB decline by 2g/dl within 24hour.
Locations
Other Locations
Saudi Arabia
Madinah maternity and children's hospital
RECRUITING
Madinah
Contact Information
Primary
Fatimah S Alhazmi, MD
f.alhazmi@hotmail.com
00 966 54 0564141
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 84
Treatments
Active_comparator: Low-threshold group
Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP phototherapy threshold.
Active_comparator: High-threshold group
Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate AAP phototherapy threshold.
Related Therapeutic Areas
Sponsors
Leads: Ministry of Health, Saudi Arabia