Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

Neonatal Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06386731
• Other study ID #: SYNEO-01
• Status: Completed
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: April 2024
• Source: Goztepe Prof Dr Suleyman Yalcin City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 28, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 15 Days

Eligibility

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.

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice
• Phototherapy Complication

Intervention

Other:
• Intermittent Phototherapy
2-hour phototherapy application in the intervention group

Locations

Country	Name	City	State
Turkey	Göztepe Prof. Dr. Suleyman Yalcin City Hopital	Kadiköy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effectiveness of CPT and IPT	The primary outcome was to compare the therapeutic efficacy of IPT and CPT	10 months
Secondary	Comparison of side effect frequency of CPT and IPT	Comparison of frequency of skin rash, increase in body temperature, diarrhea	10 months

External Links

•   Comparison of efficacy, safety & satisfaction of intermittent versus continuous phototherapy in hyperbilirubinaemic newborns =35 week gestation: A randomized controlled trial.
•   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.
•   Sixty years of phototherapy for neonatal jaundice - from serendipitous observation to standardized treatment and rescue for millions