Aggressive vs. conservative phototherapy for infants with extremely low birth weight.
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.)
Morris
Brenda H
BH
University of Texas Medical School, Houston, TX 77030, USA.
Oh
William
W
Tyson
Jon E
JE
Stevenson
David K
DK
Phelps
Dale L
DL
O'Shea
T Michael
TM
McDavid
Georgia E
GE
Perritt
Rebecca L
RL
Van Meurs
Krisa P
KP
Vohr
Betty R
BR
Grisby
Cathy
C
Yao
Qing
Q
Pedroza
Claudia
C
Das
Abhik
A
Poole
W Kenneth
WK
Carlo
Waldemar A
WA
Duara
Shahnaz
S
Laptook
Abbot R
AR
Salhab
Walid A
WA
Shankaran
Seetha
S
Poindexter
Brenda B
BB
Fanaroff
Avroy A
AA
Walsh
Michele C
MC
Rasmussen
Maynard R
MR
Stoll
Barbara J
BJ
Cotten
C Michael
CM
Donovan
Edward F
EF
Ehrenkranz
Richard A
RA
Guillet
Ronnie
R
Higgins
Rosemary D
RD
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
D001663:Bilirubin