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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Lucile Packard Children's Hospital | OTHER |
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Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled trial.
Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous phototherapy in extremely low birth weight (ELBW) infants without the risks that have been associated with continuous phototherapy.
Phototherapy (PT) is widely used and assumed to be safe as well as effective in reducing total bilirubin (TB) levels. Our recent NICHD Network Trial showed that aggressive use of phototherapy reduces neurodevelopmental impairment (NDI), but may increase deaths among ELBW infants. Among ventilator treated infants <750 g birth weight (BW) (n =696), conservative Bayesian analyses (using a neutral prior probability) identified a 99% (posterior) probability that aggressive phototherapy reduced profound NDI but a 99% probability that it increased deaths relative to conservative phototherapy. The possibility that PT increases deaths among high risk infants is also suggested by the Collaborative Phototherapy trial (performed in the 1970s), the only large RCT in which LBW infants were randomly assigned to receive PT or no PT. The relative risk for death among those randomized to PT relative to those randomized to no PT was 1.32 (0.9-1.82) among all LBW infants and 1.49 (0.93-2.40) among ELBW infants. These findings are consistent with a major increase in mortality but have been ignored because the p was >0.05, an error often made in ignoring important potential treatment hazards when power is limited.
Multiple studies, most performed decades ago in larger infants, found that short on/off cycles of PT (e.g. 15 min on/60 min off, 1 h on/3 h off, or 1 h on/1 h off ) are as effective as uninterrupted PT to reduce TSB. (Cycles with >6 h off PT do not appear to be as effective as uninterrupted PT). The clinical use of uninterrupted rather than cycled PT appears to be based largely on the assumption that PT is safe for all infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous (uninterrupted) phototherapy | Active Comparator | standard phototherapy |
|
| 15 minute per hour cycled phototherapy | Experimental | 15 minute per hour cycled phototherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phototherapy | Other | Cycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial . |
| Measure | Description | Time Frame |
|---|---|---|
| Brain stem auditory evoked response wave V latency | a measure of transient or permanent bilirubin neurotoxicity | 35 wks postmenstrual age or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Total Serum Bilirubin (tsb) | Total serum bilirubin (TSB) measurements will be obtained following a study protocol modeled on standard practice for monitoring TSB in ELBW newborns. | 14 days from birth |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopmental status | The Network supports and assures carefully standardized neurodevelopmental testing at 2 years adjusted age for inborn ELBW patients. The reliability of these exams is verified annually in the Network. These assessments will provide data for survival rates without impairment | 2 years adjusted age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jon E Tyson, MD | Contact | 713-500-5651 | jon.e.tyson@uth.tmc.edu | |
| Cody C Arnold, MD | Contact | (713) 500-5633 | cody.c.arnold@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jon E Tyson, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| David K Stevenson, MD | Stanford School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine - UAB Hospital | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22652561 | Background | Tyson JE, Pedroza C, Langer J, Green C, Morris B, Stevenson D, Van Meurs KP, Oh W, Phelps D, O'Shea M, McDavid GE, Grisby C, Higgins R; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Does aggressive phototherapy increase mortality while decreasing profound impairment among the smallest and sickest newborns? J Perinatol. 2012 Sep;32(9):677-84. doi: 10.1038/jp.2012.64. Epub 2012 May 31. | |
| 21272067 |
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| Survival |
The Neonatal Research Network supports and assures outcome assessment at 2 years adjusted age for inborn ELBW patients. These assessments will provide data for survival rates and survival rates without impairment |
| Before discharge from the neonatal ICU and at 2 years adjusted age |
| Stanford University - Lucile Packard Children's Hospital | Not yet recruiting | Palo Alto | California | 94304 | United States |
|
| University of Cincinnati College of Medicine - Good Samaritan Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| The University of Texas Southwestern Medical School - Clements University Hospital | Recruiting | Dallas | Texas | 75390 | United States |
|
| The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU | Recruiting | Houston | Texas | 77030 | United States |
|
| The University of Texas Health Science Center at San Antonio - University Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Background |
| Hintz SR, Stevenson DK, Yao Q, Wong RJ, Das A, Van Meurs KP, Morris BH, Tyson JE, Oh W, Poole WK, Phelps DL, McDavid GE, Grisby C, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Is phototherapy exposure associated with better or worse outcomes in 501- to 1000-g-birth-weight infants? Acta Paediatr. 2011 Jul;100(7):960-5. doi: 10.1111/j.1651-2227.2011.02175.x. Epub 2011 Feb 25. |
| 32338720 | Derived | Arnold C, Tyson JE, Pedroza C, Carlo WA, Stevenson DK, Wong R, Dempsey A, Khan A, Fonseca R, Wyckoff M, Moreira A, Lasky R. Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial. JAMA Pediatr. 2020 Jul 1;174(7):649-656. doi: 10.1001/jamapediatrics.2020.0559. |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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