Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?

June 15, 2016 updated by: Jon Edward Tyson, The University of Texas Health Science Center, Houston

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham School of Medicine - UAB Hospital
        • Contact:
        • Principal Investigator:
          • Wally F Carlo, MD
    • California
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford University - Lucile Packard Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • David K Stevenson, MD
        • Sub-Investigator:
          • Ron Wong, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • University of Cincinnati College of Medicine - Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Brenda Poindexter, MD, MS
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • The University of Texas Southwestern Medical School - Clements University Hospital
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joh E Tyson, MD
        • Sub-Investigator:
          • Cody C Arnold, MD
        • Sub-Investigator:
          • Mona Khan, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Science Center at San Antonio - University Hospital
        • Contact:
        • Principal Investigator:
          • Alvaro Moreira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • birth weight 401-1000 grams
  • age less than or equal to 24 hours

Exclusion Criteria:

  • hemolytic disease
  • major anomaly
  • overt nonbacterial infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: continuous (uninterrupted) phototherapy
standard phototherapy
Other: phototherapy
Cycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial .
EXPERIMENTAL: 15 minute per hour cycled phototherapy
Other: phototherapy
Cycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain stem auditory evoked response wave V latency
Time Frame: 35 wks postmenstrual age or discharge
a measure of transient or permanent bilirubin neurotoxicity
35 wks postmenstrual age or discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Total Serum Bilirubin (tsb)
Time Frame: 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.
14 days from birth

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopmental status
Time Frame: 2 years adjusted age
The Network supports and assures carefully standardized neurodevelopmental testing at 2 years adjusted age for inborn ELBW patients. The reliability of these exams is verified annually in the Network. These assessments will provide data for survival rates without impairment
2 years adjusted age
Survival
Time Frame: Before discharge from the neonatal ICU and at 2 years adjusted age
The Neonatal Research Network supports and assures outcome assessment at 2 years adjusted age for inborn ELBW patients. These assessments will provide data for survival rates and survival rates without impairment
Before discharge from the neonatal ICU and at 2 years adjusted age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Stanford University
Lucile Packard Children's Hospital

Investigators

  • Principal Investigator: Jon E Tyson, MD, The University of Texas Health Science Center, Houston
  • Principal Investigator: David K Stevenson, MD, Stanford School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (ESTIMATE)

September 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-13-0406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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