Recruiting

Cycled Phototherapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT01944696

Conditions

Hyperbilirubinemia

Premature Newborns

Extremely Low Birth Weight

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

phototherapy

Study Details

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.

Conditions

Hyperbilirubinemia

Premature Newborns

Extremely Low Birth Weight

Study ID

NCT01944696

Start date

Mar, 2014

Status verified date

Jun, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: continuous (uninterrupted) phototherapy

standard phototherapy

experimental: 15 minute per hour cycled phototherapy

15 minute per hour cycled phototherapy

Interventions

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 .

Primary outcome measure

  • Brain stem auditory evoked response wave V latency [ Time Frame: 35 wks postmenstrual age or discharge ]

Central Contacts and Locations

Central contacts

Jon E Tyson, MD

713-500-5651jon.e.tyson@uth.tmc.edu

Cody C Arnold, MD

(713) 500-5633cody.c.arnold@uth.tmc.edu

Locations

University of Alabama at Birmingham School of Medicine - UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Wally F Carlo, MD

WCarlo@peds.uab.edu

Principal Investigator:

Wally F Carlo, MD

University of Cincinnati College of Medicine - Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Brenda Poindexter, MD, MS

Brenda.Poindexter@cchmc.org

Principal Investigator:

Brenda Poindexter, MD, MS

The University of Texas Southwestern Medical School - Clements University Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Myra Wyckoff, MD

Myra.Wyckoff@UTSouthwestern.edu

Principal Investigator:

Myra Wyckoff, MD

The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU

Recruiting

Houston, Texas, United States, 77030

Contacts

Jon E Tyson, MD

713-500-5651jon.e.tyson@uth.tmc.edu

Cody C Arnold, MD

(713) 500-5633cody.c.arnold@uth.tmc.edu

Principal Investigator:

Joh E Tyson, MD

The University of Texas Health Science Center at San Antonio - University Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Alvaro Moreira, MD

moreiraA@uthscsa.edu

Principal Investigator:

Alvaro Moreira, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 16, 2016

Last verified

Jun, 2016

Keywords

  • hyperbilirubinemia
  • prematurity
  • extremely low birth weight (ELBW)
  • phototherapy
  • cycled phototherapy
  • intermittent phototherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2016-06-16.