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Background It is unclear whether aggressive phototherapy to prevent neurotoxic effects of bilirubin benefits or harms infants with extremely low birth weight (1000 g or less).
Methods We randomly assigned 1974 infants with extremely low birth weight at 12 to 36 hours of age to undergo either aggressive or conservative phototherapy. The primary outcome was a composite of death or neurodevelopmental impairment determined for 91% of the infants by investigators who were unaware of the treatment assignments.
Results Aggressive phototherapy, as compared with conservative phototherapy, significantly reduced the mean peak serum bilirubin level (7.0 vs. 9.8 mg per deciliter [120 vs. 168 µmol per liter], P<0.01) but not the rate of the primary outcome (52% vs. 55%; relative risk, 0.94; 95% confidence interval [CI], 0.87 to 1.02; P=0.15). Aggressive phototherapy did reduce rates of neurodevelopmental impairment (26%, vs. 30% for conservative phototherapy; relative risk, 0.86; 95% CI, 0.74 to 0.99). Rates of death in the aggressive-phototherapy and conservative-phototherapy groups were 24% and 23%, respectively (relative risk, 1.05; 95% CI, 0.90 to 1.22). In preplanned subgroup analyses, the rates of death were 13% with aggressive phototherapy and 14% with conservative phototherapy for infants with a birth weight of 751 to 1000 g and 39% and 34%, respectively (relative risk, 1.13; 95% CI, 0.96 to 1.34), for infants with a birth weight of 501 to 750 g.
Conclusions Aggressive phototherapy did not significantly reduce the rate of death or neurodevelopmental impairment. The rate of neurodevelopmental impairment alone was significantly reduced with aggressive phototherapy. This reduction may be offset by an increase in mortality among infants weighing 501 to 750 g at birth. (ClinicalTrials.gov number, NCT00114543
[ClinicalTrials.gov]
.)
Source Information
From the University of Texas Medical School, Houston (B.H.M., J.E.T., G.E.M.); Women and Infants Hospital, Brown University, Providence, RI (W.O., B.R.V., A.R.L.); Stanford University School of Medicine, Palo Alto, CA (D.K.S., K.P.V.M.); University of Rochester School of Medicine and Dentistry, Rochester, NY (D.L.P., R.G.); Wake Forest University School of Medicine, Winston-Salem, NC (T.M.O.); RTI International, Research Triangle Park, NC (R.L.P., Q.Y., W.K.P.), and Rockville, MD (A.D.); University of Cincinnati, Cincinnati (C.G., E.F.D.); University of Texas School of Public Health, Houston (C.P.); University of Alabama at Birmingham, Birmingham (W.A.C.); University of Miami Miller School of Medicine, Miami (S.D.); University of Texas Southwestern Medical Center, Dallas (W.A.S.); Wayne State University, Detroit (S.S.); Riley Hospital for Children, Indiana University, Indianapolis (B.B.P.); Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland (A.A.F., M.C.W.); University of California, Sharp Mary Birch Hospital for Women, San Diego (M.R.R.); Emory University, Atlanta (B.J.S.); Duke University, Durham, NC (C.M.C.); Yale University School of Medicine, New Haven, CT (R.A.E.); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (R.D.H.).
Address reprint requests to Dr. Tyson at the Department of Pediatrics, University of Texas Medical School at Houston, 6431 Fannin, MSB 3.226, Houston, TX 77030, or at jon.e.tyson{at}uth.tmc.edu.
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