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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Fatema Sulaiman Alhazmi, Ministry of Health, Saudi Arabia

Study Description
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Brief Summary:

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
Hemolytic Disease of Newborn Neonatal Hyperbilirubinemia Device: phototherapy Not Applicable

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of phototherapy [ Time Frame: 28 days ]
    Duration of phototherapy

  2. Length of hospital stay [ Time Frame: 28 days ]
    Length of hospital stay

  3. Adverse effects related to phototherapy [ Time Frame: 28 days ]
    Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration

  4. 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.

  5. 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

  6. 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

  7. Total Cost of NICU Care [ Time Frame: 90 days ]
    Total Cost of NICU Care


Eligibility Criteria
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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
  2. HGB decline by 2g/dl within 24hour.

Exclusion Criteria:

  • Major congenital abnormalities,
  • Surgical problems,
  • Direct hyperbilirubinemia
  • Sepsis
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Fatimah S Alhazmi, MD 00 966 54 0564141 f.alhazmi@hotmail.com

Locations
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Saudi Arabia
Madinah maternity and children's hospital Recruiting
Medina, Saudi Arabia, 42319
Sponsors and Collaborators
Ministry of Health, Saudi Arabia
Investigators
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Principal Investigator: Fatimah S Alhazmi, MD Ministry of Health, Saudi Arabia
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatema Sulaiman Alhazmi, Ministry of Health, Saudi Arabia:
Jaundice
Newborn
Hyperbilirubinemia
 Rebound hyperbilirubinemia
Phototherapy
Hemolysis
Additional relevant MeSH terms:
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Erythroblastosis, Fetal
Hyperbilirubinemia, Neonatal
Hemolysis
Hyperbilirubinemia
Pathologic Processes
 Infant, Newborn, Diseases
Fetal Diseases
Pregnancy Complications
Hematologic Diseases
Immune System Diseases