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Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06386731
Enrollment
225
Registered
2024-04-26
Start date
2022-07-05
Completion date
2023-04-28
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice, Phototherapy Complication

Keywords

indirect hyperbilirubinemia, continuous phototherapy, intermittent phototherapy, phototherapy side effects

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.

Detailed description

n the intermittent phototherapy group, phototherapy will be applied for 1 hour and phototherapy will be turned off for 2 hours, allowing time for the skin to be cleaned. 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. 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. It was planned to compare the effectiveness of the two groups in terms of the bilirubin level reduced as a result of 6-hour sessions, hourly reduction rate, rebound bilirubin level, total phototherapy time received, hospitalization time, and additional treatments required. It was planned to compare both groups in terms of the frequency of side effects such as the number of defecations, body temperature changes, and skin rash during the phototherapy session.

Interventions

OTHERIntermittent Phototherapy

2-hour phototherapy application in the intervention group

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
1 Days to 15 Days
Healthy volunteers
No

Inclusion criteria

The inclusion criteria was being a late preterm or term neonate who had IHB in the first 15 days of life-

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the effectiveness of CPT and IPT10 monthsThe primary outcome was to compare the therapeutic efficacy of IPT and CPT

Secondary

MeasureTime frameDescription
Comparison of side effect frequency of CPT and IPT10 monthsComparison of frequency of skin rash, increase in body temperature, diarrhea

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026