Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted)
 phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth
 weight newborns in a pilot randomized controlled trial.

 Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous
 phototherapy in extremely low birth weight (ELBW) infants without the risks that have been
 associated with continuous phototherapy.
Phototherapy (PT) is widely used and assumed to be safe as well as effective in reducing
 total bilirubin (TB) levels. Our recent NICHD Network Trial showed that aggressive use of
 phototherapy reduces neurodevelopmental impairment (NDI), but may increase deaths among ELBW
 infants. Among ventilator treated infants <750 g birth weight (BW) (n =696), conservative
 Bayesian analyses (using a neutral prior probability) identified a 99% (posterior)
 probability that aggressive phototherapy reduced profound NDI but a 99% probability that it
 increased deaths relative to conservative phototherapy. The possibility that PT increases
 deaths among high risk infants is also suggested by the Collaborative Phototherapy trial
 (performed in the 1970s), the only large RCT in which LBW infants were randomly assigned to
 receive PT or no PT. The relative risk for death among those randomized to PT relative to
 those randomized to no PT was 1.32 (0.9-1.82) among all LBW infants and 1.49 (0.93-2.40)
 among ELBW infants. These findings are consistent with a major increase in mortality but have
 been ignored because the p was >0.05, an error often made in ignoring important potential
 treatment hazards when power is limited.

 Multiple studies, most performed decades ago in larger infants, found that short on/off
 cycles of PT (e.g. 15 min on/60 min off, 1 h on/3 h off, or 1 h on/1 h off ) are as effective
 as uninterrupted PT to reduce TSB. (Cycles with >6 h off PT do not appear to be as effective
 as uninterrupted PT). The clinical use of uninterrupted rather than cycled PT appears to be
 based largely on the assumption that PT is safe for all infants.
Inclusion Criteria:

 -  birth weight 401-1000 grams

 -  age less than or equal to 24 hours

 Exclusion Criteria:

 -  hemolytic disease

 -  major anomaly

 -  overt nonbacterial infection