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Light Therapy

Cycled Phototherapy for Premature Infants

N/A
Recruiting
Led By Jon Tyson, MD
Research Sponsored by NICHD Neonatal Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant is 12-36 hours of age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 26 months corrected age
Awards & highlights

Study Summary

This trial suggests that for very premature infants, cycled phototherapy (PT) is better than continuous PT in terms of survival.

Who is the study for?
This trial is for extremely premature infants who weigh ≤ 750 grams or are born before 27 weeks of gestation. They must be between 12-36 hours old and born at the hospital conducting the study. Infants with previous phototherapy, certain blood conditions, infections, major anomalies, or those critically ill aren't eligible.Check my eligibility
What is being tested?
The trial is testing if cycled phototherapy (turning lights on and off) improves survival rates in these tiny babies compared to continuous light exposure. It's focused on very small preemies who often face health challenges due to early birth.See study design
What are the potential side effects?
Phototherapy may cause side effects like changes in water balance in the body, temporary rash-like skin changes, and can sometimes affect a baby’s feeding pattern or temperature regulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is between 12 to 36 hours old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 26 months corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 26 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants survival to discharge
Secondary outcome measures
Bilirubin
Number of Participants with Bronchopulmonary dysplasia (BPD), as a component predischarge morbidity
Number of Participants with Grade 3 (or greater) retinopathy of prematurity (ROP), as a component predischarge morbidity
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cycled PhototherapyExperimental Treatment1 Intervention
Cycled phototherapy at timed intervals, dependent upon total serum bilirum (TSB) levels.
Group II: Continuous PhototherapyActive Control1 Intervention
Continuous phototherapy

Find a Location

Who is running the clinical trial?

NICHD Neonatal Research NetworkLead Sponsor
59 Previous Clinical Trials
204,070 Total Patients Enrolled
2 Trials studying Jaundice
2,509 Patients Enrolled for Jaundice
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,679,093 Total Patients Enrolled
2 Trials studying Jaundice
233 Patients Enrolled for Jaundice
Jon Tyson, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Cycled Phototherapy (Light Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03927833 — N/A
Jaundice Research Study Groups: Continuous Phototherapy, Cycled Phototherapy
Jaundice Clinical Trial 2023: Cycled Phototherapy Highlights & Side Effects. Trial Name: NCT03927833 — N/A
Cycled Phototherapy (Light Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03927833 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are the test sites for this clinical trial?

"There are 15 enrolling patients for this study such as University of Rochester in Rochester, University of Texas Southwestern Medical Center at Dallas in Dallas, and Brown University - Women and Infants Hospital of Rhode island in Providence,to name a few 15 other locations."

Answered by AI

Can patients that are over 30 years old join this clinical trial?

"This study is currently enrolling patients that are under 27 weeks old and over 22 weeks old."

Answered by AI

Are there any studies that show the safety of using light therapy?

"Since this is a phase 3 trial, meaning that there is evidence of efficacy and multiple rounds of data supporting safety, we believe that the safety of phototherapy lights is a 3."

Answered by AI

Are they looking for more individuals to participate in this clinical trial at the moment?

"The given data from clinicaltrials.gov tells us that this clinical trial is still looking for eligible patients to participate. The trial was first posted on 7/15/2020, with the most recent update being 9/26/2022."

Answered by AI

Could I qualify to enroll in this research?

"1700 infants suffering from hyperbilirubinemia and aged between 22 and 27 weeks old can be admitted into this clinical trial. Most notably, applicants should meet the following criteria: Infants is inborn, Infant is ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OB estimate, Infant is 12-36 hours of age."

Answered by AI
~375 spots leftby Jul 2025