Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
- Conditions
- Premature NewbornsHyperbilirubinemiaExtremely Low Birth Weight
- Interventions
- Other: phototherapy
- Registration Number
- NCT01944696
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- birth weight 401-1000 grams
- age less than or equal to 24 hours
- hemolytic disease
- major anomaly
- overt nonbacterial infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description continuous (uninterrupted) phototherapy phototherapy standard phototherapy 15 minute per hour cycled phototherapy phototherapy 15 minute per hour cycled phototherapy
- Primary Outcome Measures
Name Time Method Brain stem auditory evoked response wave V latency 35 wks postmenstrual age or discharge a measure of transient or permanent bilirubin neurotoxicity
- Secondary Outcome Measures
Name Time Method Peak Total Serum Bilirubin (tsb) 14 days from birth Total serum bilirubin (TSB) measurements will be obtained following a study protocol modeled on standard practice for monitoring TSB in ELBW newborns.
Trial Locations
- Locations (6)
University of Alabama at Birmingham School of Medicine - UAB Hospital
🇺🇸Birmingham, Alabama, United States
The University of Texas Health Science Center at San Antonio - University Hospital
🇺🇸San Antonio, Texas, United States
Stanford University - Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States
The University of Texas Southwestern Medical School - Clements University Hospital
🇺🇸Dallas, Texas, United States
The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU
🇺🇸Houston, Texas, United States
University of Cincinnati College of Medicine - Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States