Phototherapy lights for Jaundice

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stanford University, Palo Alto, CAJaundice+1 MorePhototherapy lights - Device
Eligibility
22 - 27
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Jaundice
  • Premature Infants

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Betamethasone
1
Additional 2 weeks of CPAP
1
Intervention for cerebral hypoxia

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Birth to 26 months corrected age

Month 26
Number of Participants with Neurodevelopmental Impairment
Number of Participants with Neurodevelopmental Impairment or Death
Day 120
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
Number of Participants with Late onset sepsis, as a component predischarge morbidity
Number of Participants with Major neonatal morbidity
Enterocolitis
Number of Participants with Patent ductus arteriosus (PDA) treated with surgery or NSAIDS
Number of Participants with Severe ICH, as a component of the predischarge morbidity
Leukoencephalopathy
Number of participants survival to discharge
Week 2
Bilirubin
Number of hours of Phototherapy
Number of irradiance hours
Peak Concentration of Total Serum Bilirubin

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Betamethasone
2
Additional 2 weeks of CPAP
2
Intervention for cerebral hypoxia

Trial Design

2 Treatment Groups

Continuous Phototherapy
1 of 2
Cycled Phototherapy
1 of 2

Active Control

Experimental Treatment

1700 Total Participants · 2 Treatment Groups

Primary Treatment: Phototherapy lights · No Placebo Group · Phase 3

Cycled Phototherapy
Device
Experimental Group · 1 Intervention: Phototherapy lights · Intervention Types: Device
Continuous Phototherapy
Device
ActiveComparator Group · 1 Intervention: Phototherapy lights · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: birth to 26 months corrected age

Who is running the clinical trial?

NICHD Neonatal Research NetworkLead Sponsor
59 Previous Clinical Trials
204,350 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
1,840 Previous Clinical Trials
2,161,120 Total Patients Enrolled
2 Trials studying Jaundice
233 Patients Enrolled for Jaundice
Jon Tyson, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 22 - 27 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study does not include newborn babies.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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