Clinical trial NCT06386731: Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice
Official title: Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Jaundice
Phototherapy Complication
Keywords: indirect hyperbilirubinemia
continuous phototherapy
intermittent phototherapy
phototherapy side effects
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 225
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the effectiveness of CPT and IPT
timeFrame: 10 months
Secondary outcomes:
measure: Comparison of side effect frequency of CPT and IPT
timeFrame: 10 months
Other outcomes:
Locations:
city: Kadıköy
country: Turkey
facility: Göztepe Prof. Dr. Suleyman Yalcin City Hopital
state: İstanbul
Study officials:
affiliation: İstanbul medeniyet University
name: Fahri Ovalı, Prof
role: STUDY_CHAIR
References: