Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

Goztepe Prof Dr Suleyman Yalcın City Hospital

Status: Completed

Conditions: Phototherapy Complication; Neonatal Jaundice

Treatments: Other: Intermittent Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06386731

SYNEO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 1 to 15 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

intermittent phototherapy group

Active Comparator group

Description:

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.

Treatment:

Other: Intermittent Phototherapy

continuous phototherapy group

Other group

Description:

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.

Treatment:

Other: Intermittent Phototherapy