1700 Participants Needed

Cycled Phototherapy for Premature Infants

Recruiting at 18 trial locations
AD
JT
Overseen ByJon Tyson, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: NICHD Neonatal Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of cycled phototherapy for premature infants?

The concept of cycled or intermittent therapy, as seen in HIV treatments, suggests potential benefits like reduced toxicity and improved quality of life, which might be applicable to cycled phototherapy for premature infants.12345

How does cycled phototherapy differ from other treatments for premature infants?

Cycled phototherapy, also known as intermittent phototherapy, involves alternating periods of light exposure and darkness, which may help improve health outcomes in premature infants by mimicking natural day-night cycles. This approach is different from continuous phototherapy, which provides constant light exposure, and may offer practical benefits like improved feeding and bonding.678910

What is the purpose of this trial?

Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).

Research Team

JT

Jon E. Tyson, MD MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

Infant is ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OB estimate
The study does not include newborn babies.
My baby is between 12 to 36 hours old.

Exclusion Criteria

TSB reported as >6.0 mg/dL before 12 hours age
I have undergone phototherapy before.
The infant is very sick and may not survive much longer. The doctors have recommended limiting or stopping care, or the parents have asked to stop care. The infant's blood is not carrying enough oxygen and their heart rate is too slow for more than two hours.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either cycled or continuous phototherapy based on randomization

2 weeks
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 120 days

Long-term follow-up

Participants are assessed for neurodevelopmental impairment

Up to 26 months corrected age

Treatment Details

Interventions

  • Cycled Phototherapy
Trial Overview 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.
Participant Groups
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

Cycled Phototherapy is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Cycled Phototherapy for:
  • Neonatal jaundice (hyperbilirubinemia) in extremely low birth weight infants
🇪🇺
Approved in European Union as Intermittent Phototherapy for:
  • Neonatal jaundice (hyperbilirubinemia) in preterm infants

Find a Clinic Near You

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials
62
Recruited
209,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

In a study of HIV-infected adults on a short-cycle therapy (SCT) regimen with rilpivirine, 100% of participants maintained virological suppression after 48 weeks, demonstrating the efficacy of this treatment approach.
The SCT regimen also resulted in high patient satisfaction (average score of 57.7/60) and no adverse events, suggesting it is a safe and effective alternative to continuous therapy for selected patients.
Short-cycle therapy in HIV-infected adults: rilpivirine combination 4 days on/3 days off therapy.Luise, D., Lattuada, E., Rizzardo, S., et al.[2022]
In a study involving 199 HIV-1-infected young people, short cycle therapy (5 days on, 2 days off ART) was found to be non-inferior to continuous therapy in maintaining viral suppression over 48 weeks, with only 6% of participants in the short cycle group experiencing viral loads above 50 copies per mL.
Short cycle therapy demonstrated a better safety profile, with significantly fewer ART-related adverse events compared to continuous therapy (2 vs. 14 events), making it a promising option for young patients stable on efavirenz-based ART.
Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial.[2021]
A once-daily short-cycle structured intermittent therapy (SIT) regimen effectively maintained suppression of plasma HIV RNA in 7 out of 8 patients for 60-84 weeks, demonstrating its potential as a viable treatment option.
The regimen preserved CD4(+) T cell counts and did not significantly alter liver enzyme or lipid levels, suggesting it is a safe alternative to continuous antiretroviral therapy, especially in resource-limited settings.
A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection.Dybul, M., Nies-Kraske, E., Dewar, R., et al.[2020]

References

Short-cycle therapy in HIV-infected adults: rilpivirine combination 4 days on/3 days off therapy. [2022]
Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. [2021]
A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection. [2020]
Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. [2023]
Prospective randomized comparison of two prophylactic regimens with trimethoprim-sulfamethoxazole in leukemic children: a two year study. [2019]
Efficacy of phototherapy devices and outcomes among extremely low birth weight infants: multi-center observational study. [2022]
Efficacy of Intermittent Phototherapy versus Continuous Phototherapy for Treatment of Neonatal Hyperbilirubinaemia: A Systematic Review and Meta-analysis. [2021]
Effect of phototherapy in preterm infants on growth in the neonatal period. [2019]
Intermittent phototherapy versus continuous phototherapy for neonatal jaundice. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Timing for the Introduction of Cycled Light for Extremely Preterm Infants: A Randomized Controlled Trial. [2018]
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