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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Primary Purpose

Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
phototherapy
Sponsored by
Ministry of Health, Saudi Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemolytic Disease of Newborn focused on measuring Jaundice, Newborn, Hyperbilirubinemia, Rebound hyperbilirubinemia, Phototherapy, Hemolysis

Eligibility Criteria

1 Hour - 14 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Madinah maternity and children's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-threshold group

High-threshold group

Arm Description

Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP phototherapy threshold.

Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate AAP phototherapy threshold.

Outcomes

Primary Outcome Measures

Rebound hyperbilirubinemia
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

Duration of phototherapy
Duration of phototherapy
Length of hospital stay
Length of hospital stay
Adverse effects related to phototherapy
Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration
Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage
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
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
Number of participants of whome rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
Total Cost of NICU Care
Total Cost of NICU Care

Full Information

First Posted
December 18, 2019
Last Updated
February 1, 2020
Sponsor
Ministry of Health, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT04218318
Brief Title
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
Official Title
Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
November 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia
Keywords
Jaundice, Newborn, Hyperbilirubinemia, Rebound hyperbilirubinemia, Phototherapy, Hemolysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective open labeled randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-threshold group
Arm Type
Active Comparator
Arm Description
Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP phototherapy threshold.
Arm Title
High-threshold group
Arm Type
Active Comparator
Arm Description
Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate AAP phototherapy threshold.
Intervention Type
Device
Intervention Name(s)
phototherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rebound hyperbilirubinemia
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Duration of phototherapy
Description
Duration of phototherapy
Time Frame
28 days
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
28 days
Title
Adverse effects related to phototherapy
Description
Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration
Time Frame
28 days
Title
Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage
Description
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.
Time Frame
28 days
Title
Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
Description
Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
Time Frame
28 days
Title
Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
Description
Number of participants of whome rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
Time Frame
28 days
Title
Total Cost of NICU Care
Description
Total Cost of NICU Care
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatimah S Alhazmi, MD
Phone
00 966 54 0564141
Email
f.alhazmi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatimah S Alhazmi, MD
Organizational Affiliation
Ministry of Health, Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madinah maternity and children's hospital
City
Medina
ZIP/Postal Code
42319
Country
Saudi Arabia
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

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