Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

NCT06386731 | Completed

• 1 other identifier: SYNEO-01
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy.

Conditions

Neonatal Jaundice; Phototherapy Complication

Keywords

indirect hyperbilirubinemia; continuous phototherapy; intermittent phototherapy; phototherapy side effects

Outcome Measures

Primary Outcomes (1)

• Comparison of the effectiveness of CPT and IPT

  The primary outcome was to compare the therapeutic efficacy of IPT and CPT

  10 months

Secondary Outcomes (1)

• Comparison of side effect frequency of CPT and IPT

  10 months

Study Arms (2)

intermittent phototherapy group

ACTIVE COMPARATOR

In the intermittent phototherapy group, phototherapy will be applied for 1 hour, phototherapy will be turned off for 2 hours, and time will be left for cleansing from the skin. The 3-hour cycle is completed twice and the 6-hour session is completed, and at the end, the total bilirubin will be measured and the hourly bilirubin decrease rate will be calculated.

Other: Intermittent Phototherapy

continuous phototherapy group

OTHER

In the continuous phototherapy group, total bilirubin will be measured at the end of 6 hours of uninterrupted phototherapy and the hourly bilirubin decrease rate will be calculated.

Other: Intermittent Phototherapy

Interventions

Intermittent Phototherapy OTHER

2-hour phototherapy application in the intervention group

Also known as: Phototherapy duration

continuous phototherapy group; intermittent phototherapy group

Eligibility Criteria

• Age: 1 Day - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Those who had sTB values at the blood exchange limit according to the nomogram, any associated congenital anomalies including chromosomal anomalies or were less than 34th gestational week were excluded.

Sponsors & Collaborators

• Goztepe Prof Dr Suleyman Yalcın City Hospital: lead

Study Sites (1)

Göztepe Prof. Dr. Suleyman Yalcin City Hopital

Kadıköy, Istanbul, 34730, Turkey (Türkiye)

Location

Related Links

• Intermittent versus continuous phototherapy for the treatment of neonatal non-hemolytic moderate hyperbilirubinemia in infants more than 34 weeks of gestational age: a randomized controlled trial.
• Comparison of efficacy, safety \& satisfaction of intermittent versus continuous phototherapy in hyperbilirubinaemic newborns ≥35 week gestation: A randomized controlled trial.
• Sixty years of phototherapy for neonatal jaundice - from serendipitous observation to standardized treatment and rescue for millions

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fahri Ovalı, Prof

  İstanbul medeniyet University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric clinic chief assistant, MD

Model Details: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: July 5, 2022
• Primary Completion: November 25, 2022
• Study Completion: April 28, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years
• Access Criteria: Medical doctors and medical students who will conduct research on the subject can access the data.

Locations

TU (1)