Hyperbilirubinemia Clinical Trial
Official title:
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | January 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 24 Hours |
Eligibility |
Inclusion Criteria: - birth weight 401-1000 grams - age less than or equal to 24 hours Exclusion Criteria: - hemolytic disease - major anomaly - overt nonbacterial infection |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham School of Medicine - UAB Hospital | Birmingham | Alabama |
United States | University of Cincinnati College of Medicine - Good Samaritan Hospital | Cincinnati | Ohio |
United States | The University of Texas Southwestern Medical School - Clements University Hospital | Dallas | Texas |
United States | The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU | Houston | Texas |
United States | Stanford University - Lucile Packard Children's Hospital | Palo Alto | California |
United States | The University of Texas Health Science Center at San Antonio - University Hospital | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | Lucile Packard Children's Hospital, Stanford University |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Yes |
Other | 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 | Yes |
Primary | Brain stem auditory evoked response wave V latency | a measure of transient or permanent bilirubin neurotoxicity | 35 wks postmenstrual age or discharge | Yes |
Secondary | 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 | Yes |
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