Cycled Phototherapy for Premature Infants
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NICHD Neonatal Research Network
Disqualifiers: Hemolytic disease, Major anomaly, Nonbacterial infection, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
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).
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.
12345How 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.
678910Eligibility 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.
+4 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern Medical Center at DallasDallas, TX
Cincinnati Children's Medical CenterCincinnati, OH
Northwestern Lurie Children's Hospital of ChicagoChicago, IL
Emory UniversityAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
NICHD Neonatal Research NetworkLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Short-cycle therapy in HIV-infected adults: rilpivirine combination 4 days on/3 days off therapy. [2022]Short-cycle therapy (SCT) is the administration of ART for 4 or 5 consecutive days a week, followed by 3 or 2 days off therapy. Its benefits include improving patient satisfaction and reducing ART toxicity and costs.
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]For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).
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]We previously demonstrated that short-cycle structured intermittent therapy (SIT; 7 days without therapy followed by 7 days with antiretroviral therapy [ART]) with a ritonavir-boosted, indinavir-based, twice-daily regimen maintained suppression of plasma HIV viremia while reducing serum levels of lipids. Adherence to such a regimen may be problematic for certain patients.
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]Increasing the dose intensity of cytotoxic therapy by shortening the intervals between cycles, or by giving individual drugs sequentially at full dose rather than in lower-dose concurrent treatment schedules, might enhance efficacy.
Prospective randomized comparison of two prophylactic regimens with trimethoprim-sulfamethoxazole in leukemic children: a two year study. [2019]Between 1 July 1984 and 30 June 1986 all children treated for acute hematologic malignancy at our center were randomized to receive continuous (group A) or intermittent (3 days/week, group B) prophylaxis with trimethoprim-sulfamethoxazole (5-25 mg/kg/day/p.o.) against interstitial pneumonia with the aim of investigating if an intermittent regimen is as effective as and less toxic than a continuous regimen. The number of severe infections (group A, 17; group B, 21) and side-effects (group A, 30; group B, 34) was similar in the two groups, and compliance was also similar. We conclude therefore that neither regimen offers advantages over the other and the decision which to use should be based on cost (where regimen B has the advantage) and the children's and parents' preferences and compliance.
Efficacy of phototherapy devices and outcomes among extremely low birth weight infants: multi-center observational study. [2022]Evaluate the efficacy of phototherapy (PT) devices and the outcomes of extremely premature infants treated with those devices.
Efficacy of Intermittent Phototherapy versus Continuous Phototherapy for Treatment of Neonatal Hyperbilirubinaemia: A Systematic Review and Meta-analysis. [2021]We review the current literatures to determine whether intermittent phototherapy is more effective than continuous phototherapy in treating neonatal hyperbilirubinaemia.
Effect of phototherapy in preterm infants on growth in the neonatal period. [2019]A total of 120 preterm infants were randomly divided at 24 hr of age into three groups: Group I, controls; Group II, continuous phototherapy for 5 days; and Group III, intermittent phototherapy (12 hr on and 12 hr off) for 5 days. At the end of week 1 80% of the control group regained and surpassed their birth weight as opposed to 44 and 57.6% in the continuous and intermittent phototherapy groups, respectively. In weeks 2 and 3 both phototherapy groups had greater weight gain than the control group. Similar but less marked differences were observed in body lenth and head circumference in the three groups. Data suggest decreased growth during phototherapy with subsequent catch-up in growth during weeks 2 and 3. Differences were less marked between infants on intermittent (rather than continuous) phototherapy and controls. Increased metabolic demands and decreased intestinal absorption during phototherapy may be two of the factors responsible for the observed differences in growth in the three groups.
Intermittent phototherapy versus continuous phototherapy for neonatal jaundice. [2023]Phototherapy is a widely accepted, effective first-line therapy for neonatal jaundice. It is traditionally used continuously but intermittent phototherapy has been proposed as an equally effective alternative with practical advantages of improved maternal feeding and bonding. The effectiveness of intermittent phototherapy compared with continuous phototherapy is unknown.
Timing for the Introduction of Cycled Light for Extremely Preterm Infants: A Randomized Controlled Trial. [2018]Day-night cycled light improves health outcomes in preterm infants, yet the best time to institute cycled light is unclear. The hypothesis of this study was that extremely preterm infants receiving early cycled light would have better health and developmental outcomes than infants receiving late cycled light. Infants born at ≤28 weeks gestation were randomly assigned to early cycled light (ECL) starting at 28 weeks postmenstrual age [PMA] or late cycled light (LCL), starting at 36 weeks PMA. Daylight was 200-600 lux and night was 5-30 lux. Primary outcomes were weight over time and length of hospitalization. Secondary outcomes were hospital costs, sleep development, and neurodevelopment at 9, 18, and 24 months corrected age. Of 121 infants randomized, 118 were included in analysis. Weight gain in the two groups did not differ significantly but increased across time in both groups. In PMA weeks 36-44, the mean weight gain was 193.8 grams in the ECL group compared to 176.3 grams in the LCL group. Effect sizes for weight were Cohen d = 0.26 and 0.36 for 36 and 44 weeks PMA. Infants in the ECL group went home an average of 5.5 days earlier than the LCL group, but this difference was not statistically significant. There were no group differences on neurodevelopmental outcomes. Although statistically non-significant, clinically important differences of improved weight gain and decreased hospital stay were observed with ECL. The small observed effect sizes on weight during hospitalization should be considered in future cycled light research with extremely preterm infants. © 2017 Wiley Periodicals, Inc.