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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
Must not have
Previous phototherapy
Known hemolytic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 26 months corrected age
Awards & highlights

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
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My baby is between 12 to 36 hours old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone phototherapy before.
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I have a condition that breaks down my red blood cells.
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My infant was enrolled after 36 hours of age.
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I have a viral or fungal infection.

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
1,988 Previous Clinical Trials
2,681,823 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
~317 spots leftby Jul 2025
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