Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
NCT ID: NCT00114543
Last Updated: 2019-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1974 participants
INTERVENTIONAL
2002-09-30
2007-11-30
Brief Summary
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Detailed Description
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This NRN study used two different bilirubin levels as thresholds for timing of phototherapy in 1,978 extremely low birth weight infants, examining the primary hypothesis that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age between the aggressively and conservatively treated groups.
Enrolled infants were stratified by birth weight (501-750g and 751-1,000g) and randomized to receive phototherapy regimens based on either an aggressive threshold or a conservative threshold of total serum bilirubin.
In the Aggressive group:
* 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-14.
* 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-7 and 7 mg/dl for day of life 8-14.
In the Conservative group:
* 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 8 mg/dl for day of life 1-14.
* 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 10 mg/dl for day of life 1-14.
The phototherapy regimens are designed to fall within the range of clinical practice and to assure a sizable difference between groups in total serum bilirubin levels and duration of phototherapy.
The primary outcome was death or neurodevelopmental impairment at 18-22 months corrected age determined at an outpatient clinic visit. Secondary outcomes included death, abnormal neurodevelopmental outcome, severe hearing loss, cerebral palsy, blindness, and important medical outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aggressive ELBW
In Aggressive group 1, infants with birth weights 501-750g.
Aggressive Phototherapy 501-750g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.
Aggressive VLBW
In the Aggressive group 2, infants with birth weights 751-1000g.
Aggressive Phototherapy 751-1000g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14.
Conservative ELBW
In the Conservative group 1, infants with birth weights 501-750g.
Conservative Phototherapy 501-750g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.
Conservative VLBW
In the Conservative group 2, infants with birth weights 751-1000g.
Conservative Phototherapy 751-1000g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.
Interventions
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Aggressive Phototherapy 501-750g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.
Aggressive Phototherapy 751-1000g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14.
Conservative Phototherapy 501-750g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.
Conservative Phototherapy 751-1000g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.
Eligibility Criteria
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Inclusion Criteria
* 12-36 hours postnatal age
Exclusion Criteria
* Prior use of phototherapy
* Major congenital anomaly
* Hydrops fetalis or severe hemolytic disease diagnosed in-utero
* Overt congenital nonbacterial infection
* Parental refusal or inability to provide consent
* Attending physician refusal
* Parents who are considered unlikely to return for follow-up evaluation
12 Hours
36 Hours
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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University of Texas Health Science Center at Houston
Principal Investigators
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Abbot R. Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Brenda B. Poindexter, MD MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Abhik Das, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Ronnie Guillet, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Pablo J. Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Krisa P. Van Meurs, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Neil N. Finer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Kurt Schibler, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Waldemar A. Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Brenda H. Morris, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Richard A. Ehrenkranz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Shahnaz Duara, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
T. Michael O'Shea, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Wayne State University
Detroit, Michigan, United States
University of Rochester
Rochester, New York, United States
Wake Forest University
Charlotte, North Carolina, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Morris BH, Oh W, Tyson JE, Stevenson DK, Phelps DL, O'Shea TM, McDavid GE, Perritt RL, Van Meurs KP, Vohr BR, Grisby C, Yao Q, Pedroza C, Das A, Poole WK, Carlo WA, Duara S, Laptook AR, Salhab WA, Shankaran S, Poindexter BB, Fanaroff AA, Walsh MC, Rasmussen MR, Stoll BJ, Cotten CM, Donovan EF, Ehrenkranz RA, Guillet R, Higgins RD; NICHD Neonatal Research Network. Aggressive vs. conservative phototherapy for infants with extremely low birth weight. N Engl J Med. 2008 Oct 30;359(18):1885-96. doi: 10.1056/NEJMoa0803024.
Ahlfors CE, Vreman HJ, Wong RJ, Bender GJ, Oh W, Morris BH, Stevenson DK; Phototherapy Subcommittee; National Institute of Child Health and Development (NICHD) Neonatal Research Network. Effects of sample dilution, peroxidase concentration, and chloride ion on the measurement of unbound bilirubin in premature newborns. Clin Biochem. 2007 Feb;40(3-4):261-7. doi: 10.1016/j.clinbiochem.2006.09.006. Epub 2006 Sep 29.
Bender GJ, Cashore WJ, Oh W. Ontogeny of bilirubin-binding capacity and the effect of clinical status in premature infants born at less than 1300 grams. Pediatrics. 2007 Nov;120(5):1067-73. doi: 10.1542/peds.2006-3024.
Oh W, Stevenson DK, Tyson JE, Morris BH, Ahlfors CE, Bender GJ, Wong RJ, Perritt R, Vohr BR, Van Meurs KP, Vreman HJ, Das A, Phelps DL, O'Shea TM, Higgins RD; NICHD Neonatal Research Network Bethesda MD. Influence of clinical status on the association between plasma total and unbound bilirubin and death or adverse neurodevelopmental outcomes in extremely low birth weight infants. Acta Paediatr. 2010 May;99(5):673-678. doi: 10.1111/j.1651-2227.2010.01688.x. Epub 2010 Jan 25.
Related Links
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NICHD Neonatal Research Network
Other Identifiers
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NICHD-NRN-0029
Identifier Type: -
Identifier Source: org_study_id
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