Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
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ClinicalTrials.gov Identifier: NCT04218318 |
Recruitment Status : Unknown
Verified February 2020 by Fatema Sulaiman Alhazmi, Ministry of Health, Saudi Arabia.
Recruitment status was: Recruiting
First Posted : January 6, 2020
Last Update Posted : February 5, 2020
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We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.
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.
Condition or disease | Intervention/treatment | Phase |
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Hemolytic Disease of Newborn Neonatal Hyperbilirubinemia | Device: phototherapy | Not Applicable |
Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate 2004 AAP phototherapy threshold, whereas neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP threshold.
Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A prospective open labeled randomized control trial |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | October 31, 2020 |
Estimated Study Completion Date : | November 15, 2020 |
Arm | Intervention/treatment |
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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.
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Device: phototherapy
Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion. |
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.
|
Device: phototherapy
Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion. |
- Rebound hyperbilirubinemia [ Time Frame: 28 days ]Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold within 72 hours of phototherapy discontinuation of a neonate's first round of phototherapy treatment.
- Duration of phototherapy [ Time Frame: 28 days ]Duration of phototherapy
- Length of hospital stay [ Time Frame: 28 days ]Length of hospital stay
- Adverse effects related to phototherapy [ Time Frame: 28 days ]Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration
- Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage [ Time Frame: 28 days ]Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold between 3-7 days of phototherapy discontinuation of a neonate's first round of phototherapy treatment.
- Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage [ Time Frame: 28 days ]Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
- Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage [ Time Frame: 28 days ]Number of participants of whome rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
- Total Cost of NICU Care [ Time Frame: 90 days ]Total Cost of NICU Care

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Ages Eligible for Study: | up to 14 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
Exclusion Criteria:
- Major congenital abnormalities,
- Surgical problems,
- Direct hyperbilirubinemia
- Sepsis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218318
Contact: Fatimah S Alhazmi, MD | 00 966 54 0564141 | f.alhazmi@hotmail.com |
Saudi Arabia | |
Madinah maternity and children's hospital | Recruiting |
Medina, Saudi Arabia, 42319 |
Principal Investigator: | Fatimah S Alhazmi, MD | Ministry of Health, Saudi Arabia |
Responsible Party: | Fatema Sulaiman Alhazmi, Cilinical fellow, Madinah Maternity and Children's Hospital, NICU, Ministry of Health, Saudi Arabia |
ClinicalTrials.gov Identifier: | NCT04218318 |
Other Study ID Numbers: |
H-03-M-084 |
First Posted: | January 6, 2020 Key Record Dates |
Last Update Posted: | February 5, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Jaundice Newborn Hyperbilirubinemia |
Rebound hyperbilirubinemia Phototherapy Hemolysis |
Erythroblastosis, Fetal Hyperbilirubinemia, Neonatal Hemolysis Hyperbilirubinemia Pathologic Processes |
Infant, Newborn, Diseases Fetal Diseases Pregnancy Complications Hematologic Diseases Immune System Diseases |