Neonatal Jaundice Clinical Trial
Official title:
Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice: A Randomized Controlled Trial
NCT number | NCT06386731 |
Other study ID # | SYNEO-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 5, 2022 |
Est. completion date | April 28, 2023 |
Verified date | April 2024 |
Source | Goztepe Prof Dr Suleyman Yalcin City Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Göztepe Prof. Dr. Suleyman Yalcin City Hopital | Kadiköy | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Goztepe Prof Dr Suleyman Yalcin City Hospital |
Turkey,
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 |
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