Infant, Premature Clinical Trial
— PhototherapyOfficial title:
A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants
Verified date | September 2017 |
Source | NICHD Neonatal Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.
Status | Completed |
Enrollment | 1974 |
Est. completion date | November 2007 |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 36 Hours |
Eligibility |
Inclusion criteria: - 501-1000 grams birth weight - 12-36 hours postnatal age Exclusion criteria: - Terminal condition (pH <6.8 for >2 hours OR persistent bradycardia, heart rate <100 bpm, associated with hypoxia for >2 hours] - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Wake Forest University | Charlotte | 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 | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Wayne State University | Detroit | Michigan |
United States | Duke University | Durham | North Carolina |
United States | RTI International | Durham | North Carolina |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Miami | Miami | Florida |
United States | Yale University | New Haven | Connecticut |
United States | Stanford University | Palo Alto | California |
United States | Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | University of Rochester | Rochester | New York |
United States | University of California at San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
NICHD Neonatal Research Network | National Center for Research Resources (NCRR) |
United States,
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 i — View Citation
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. — View Citation
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, Rasmuss — View Citation
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 bet — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss) | 0-22 months corrected age | ||
Secondary | Patent ductus arteriosus requiring drug or surgical treatment | 36 weeks post conceptual age | ||
Secondary | Retinopathy of prematurity | 36 weeks post conceptual age | ||
Secondary | Bronchopulmonary dysplasia (BPD) | 36 weeks post conceptual age | ||
Secondary | Ventilator settings and FiO2 at 36 weeks | 36 weeks post conceptual age | ||
Secondary | Necrotizing enterocolitis (NEC) | 120 days old or at discharge | ||
Secondary | Intraventricular hemorrhage (IVH) by grade | 120 days old or at discharge | ||
Secondary | Periventricular leukomalacia | 120 days old or at discharge | ||
Secondary | Sepsis | 120 days old or at discharge | ||
Secondary | Hearing assessments | 120 days old or at discharge |
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