Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218318
• Other study ID #: H-03-M-084
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 15, 2020

Study information

• Verified date: February 2020
• Source: Ministry of Health, Saudi Arabia
• Contact: Fatimah S Alhazmi, MD
• Phone: 00 966 54 0564141
• Email: f.alhazmi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 15, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Erythroblastosis, Fetal
• Hemolysis
• Hemolytic Disease of Newborn
• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Madinah maternity and children's hospital	Medina

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	Duration of phototherapy	Duration of phototherapy	28 days
Secondary	Length of hospital stay	Length of hospital stay	28 days
Secondary	Adverse effects related to phototherapy	Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration	28 days
Secondary	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.	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	Total Cost of NICU Care	Total Cost of NICU Care	90 days