Trial record 9 of 29 for:    Open Studies | "Hyperbilirubinemia"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
Stanford University
Lucile Packard Children's Hospital
Wayne State University
Children's Hospital of Michigan
Information provided by (Responsible Party):
Jon Edward Tyson, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01944696
First received: September 12, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Hyperbilirubinemia
Premature Newborns
Extremely Low Birth Weight
Other: phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intermittent Phototherapy: A Safer Effective Treatment for Small Premature Infants?

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Brain stem auditory evoked response wave V latency [ Time Frame: 35 wks postmenstrual age or discharge ] [ Designated as safety issue: Yes ]
    a measure of transient or permanent bilirubin neurotoxicity


Secondary Outcome Measures:
  • Peak Total Serum Bilirubin (tsb) [ Time Frame: 14 days from birth ] [ Designated as safety issue: Yes ]
    Total serum bilirubin (TSB) measurements will be obtained following a study protocol modeled on standard practice for monitoring TSB in ELBW newborns.


Other Outcome Measures:
  • Neurodevelopmental status [ Time Frame: 2 years adjusted age ] [ Designated as safety issue: Yes ]
    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

  • Survival [ Time Frame: Before discharge from the neonatal ICU and at 2 years adjusted age ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: continuous (uninterupted) 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
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 .
Experimental: 30 minute per hour cycled phototherapy
30 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 .

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hemolytic disease
  • major anomaly
  • overt nonbacterial infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944696

Contacts
Contact: Jon E Tyson, MD 713-500-5651 jon.e.tyson@uth.tmc.edu
Contact: Cody C Arnold, MD (713) 500-5633 cody.c.arnold@uth.tmc.edu

Locations
United States, California
Stanford University - Lucile Packard Children's Hospital Not yet recruiting
Palo Alto, California, United States, 94304
Contact: David K Stevenson, MD       dstevenson@stanford.edu   
Contact: Ron Wong, MD       rjwong@stanford.edu   
Principal Investigator: David K Stevenson, MD         
Sub-Investigator: Ron Wong, MD         
United States, Michigan
Wayne State University - Children's Hospital of Michigan Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Seetha Shankaran, MD       sshankar@med.wayne.edu   
Contact: Beena Sood, MD       bsood@med.wayne.edu   
Principal Investigator: Seetha Shankaran, MD         
Principal Investigator: Beena Sood, MD         
Principal Investigator: Prem Arora, MD         
United States, Texas
The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jon E Tyson, MD    713-500-5651    jon.e.tyson@uth.tmc.edu   
Contact: Cody C Arnold, MD    (713) 500-5633    cody.c.arnold@uth.tmc.edu   
Principal Investigator: Joh E Tyson, MD         
Sub-Investigator: Cody C Arnold, MD         
Sub-Investigator: Mona Khan, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Stanford University
Lucile Packard Children's Hospital
Wayne State University
Children's Hospital of Michigan
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
  More Information

Publications:
Responsible Party: Jon Edward Tyson, Professor, Vice Dean for Clinical Research and Healthcare Quality, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01944696     History of Changes
Other Study ID Numbers: HSC-MS-13-0406
Study First Received: September 12, 2013
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
hyperbilirubinemia
prematurity
extremely low birth weight (ELBW)
phototherapy
cycled phototherapy
intermittent phototherapy

Additional relevant MeSH terms:
Birth Weight
Hyperbilirubinemia
Premature Birth
Body Weight
Signs and Symptoms
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 01, 2014