MedTrace Logo

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

NCT01944696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2016-06-16

No results posted yet for this study

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

Interventions

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 .

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER

  • Lucile Packard Children's Hospital

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jon E Tyson, MD · The University of Texas Health Science Center, Houston

  • David K Stevenson, MD · Stanford School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944696 on ClinicalTrials.gov