title: Aggressive vs. conservative phototherapy for infants with extremely low birth weight.
abstract: 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 micromol 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.)
authors.affiliation: University of Texas Medical School, Houston, TX 77030, USA.
authors.forename: Brenda H
authors.initials: BH
authors.lastname: Morris
authors.forename: William
authors.initials: W
authors.lastname: Oh
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
authors.forename: David K
authors.initials: DK
authors.lastname: Stevenson
authors.forename: Dale L
authors.initials: DL
authors.lastname: Phelps
authors.forename: T Michael
authors.initials: TM
authors.lastname: O'Shea
authors.forename: Georgia E
authors.initials: GE
authors.lastname: McDavid
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Perritt
authors.forename: Krisa P
authors.initials: KP
authors.lastname: Van Meurs
authors.forename: Betty R
authors.initials: BR
authors.lastname: Vohr
authors.forename: Cathy
authors.initials: C
authors.lastname: Grisby
authors.forename: Qing
authors.initials: Q
authors.lastname: Yao
authors.forename: Claudia
authors.initials: C
authors.lastname: Pedroza
authors.forename: Abhik
authors.initials: A
authors.lastname: Das
authors.forename: W Kenneth
authors.initials: WK
authors.lastname: Poole
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Duara
authors.forename: Abbot R
authors.initials: AR
authors.lastname: Laptook
authors.forename: Walid A
authors.initials: WA
authors.lastname: Salhab
authors.forename: Seetha
authors.initials: S
authors.lastname: Shankaran
authors.forename: Brenda B
authors.initials: BB
authors.lastname: Poindexter
authors.forename: Avroy A
authors.initials: AA
authors.lastname: Fanaroff
authors.forename: Michele C
authors.initials: MC
authors.lastname: Walsh
authors.forename: Maynard R
authors.initials: MR
authors.lastname: Rasmussen
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Stoll
authors.forename: C Michael
authors.initials: CM
authors.lastname: Cotten
authors.forename: Edward F
authors.initials: EF
authors.lastname: Donovan
authors.forename: Richard A
authors.initials: RA
authors.lastname: Ehrenkranz
authors.forename: Ronnie
authors.initials: R
authors.lastname: Guillet
authors.forename: Rosemary D
authors.initials: RD
authors.lastname: Higgins
mesh_terms: D001499:Bayes Theorem; D001663:Bilirubin / Q000097:blood; D001724:Birth Weight; D002658:Developmental Disabilities / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D051556:Hyperbilirubinemia, Neonatal / Q000150:complications / Q000628:therapy*; D007226:Infant Mortality; D052577:Infant, Extremely Low Birth Weight / Q000097:blood; D007231:Infant, Newborn; D008297:Male; D010789:Phototherapy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D001663:Bilirubin