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it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.
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The aim of this trial is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice.
Neonatal jaundice is a commonly disease. Phototherapy is performed to prevent from kernicterus.However, light sources and irradiance level are different among hospitals, and it was controversial whether the improvement of jaundice is related to the irradiance level of phototherapy or not. In addition, long-term side effects are not clear, therefore, excessive irradiation should be avoided. The purpose of this study is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice. This study is multicenter randomized controlled trial conducted by Nagoya University Hospital, Anjo Kosei Hospital, Kasugai Municipal Hospital, Handa Hospital, TOYOTA Memorial Hospital, National Hospital Organization Nagoya Medical Center, Japan Red Cross Nagoya Daiichi Hospital, Hekinan Municipal Hospital, and Ogaki Municipal Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High level irradiation | Active Comparator | High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength. |
|
| Low level irradiation | Experimental | Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High irradiance level of phototherapy | Other | High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retreatment rate of neonatal jaundice | Treatment of neonatal jaundice again after finishing phototherapy. | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo Kosei Hospital | Anjo | Aichi-ken | 446-8602 | Japan | ||
| Handa City Hospital |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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| Low irradiance level of phototherapy | Other | Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength |
|
| Handa |
| Aichi-ken |
| 475-8599 |
| Japan |
| Hekinan Municipal Hospital | Hekinan | Aichi-ken | 447-8502 | Japan |
| Kasugai Municipal Hospital | Kasugai | Aichi-ken | 486-8510 | Japan |
| Japan Red Cross Nagoya Daiichi Hospital | Nagoya | Aichi-ken | 453-8511 | Japan |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8550 | Japan |
| TOYOTA Memorial Hospital | Toyota | Aichi-ken | 471-8513 | Japan |
| Ogaki Municipal Hospital | Ōgaki | Gifu | 503-8502 | Japan |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |