Clinical Research Directory

Effectiveness of Aluminum Foil vs White Linen Reflectors in Phototherapy for Neonatal Hyperbilirubinemia

Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants. Phototherapy is the most widely used, safe, and non-invasive treatment; however, scattering of phototherapy light decreases treatment efficacy, prolongs therapy duration, and increases the risk of side effects. Reflective materials have been suggested to enhance phototherapy effectiveness, yet studies comparing different reflector types remain limited. Aim: This study aims to compare the effects of using reflective materials (white cloth or aluminum foil) during phototherapy on total serum bilirubin levels and phototherapy duration, in neonates with physiological IHB. Methods: This single-center, single-blind, randomized controlled trial will be conducted at Ankara University Faculty of Medicine, Cebeci Neonatal Intensive Care Unit. A total of 81 neonates with gestational age 35-42 weeks and total serum bilirubin levels of 15-20 mg/dl will be randomly assigned into three groups: (1) phototherapy with white cloth reflectors, (2) phototherapy with aluminum foil reflectors, and (3) standard phototherapy (control). Data will be collected using an Introductory Information Form and Daily Follow-up Chart. Statistical analyses will include parametric and non-parametric tests based on distribution assumptions, with significance set at p\<0.05. Expected Results: It is hypothesized that the use of reflective materials will result in faster reduction of total serum bilirubin and shorter phototherapy compared with standard phototherapy. Conclusion: The study will provide evidence on the comparative effectiveness of two low-cost reflector materials in enhancing phototherapy outcomes, potentially offering a practical and efficient strategy for neonatal hyperbilirubinemia management.

Comparative Study of Topical Pentoxifylline Versus Topical 5-Fluorouracil Combined With Microneedling and NB-UVB for Stable Vitiligo

This randomized, single-blinded clinical trial evaluates the efficacy and safety of topical pentoxifylline compared with topical 5-fluorouracil, both combined with microneedling and narrow-band ultraviolet B (NB-UVB) phototherapy, in patients with stable vitiligo. A total of 42 patients with stable vitiligo received six biweekly microneedling sessions over three months, with concomitant NB-UVB phototherapy twice weekly, followed by a three-month follow-up period. Each patient had three vitiliginous patches allocated to topical pentoxifylline with microneedling, topical 5-fluorouracil with microneedling, or microneedling alone.

Violet Light for the Suppression of Myopia

The study explores the suppression of myopia via violet light.

Bilirubin Thresholds in Preterm Infants on Neonatal Intensive CarE Units: The B-NICE Trial

Rationale: Neonatal hyperbilirubinemia is highly prevalent in very preterm infants born \<30 weeks. Since 2008, uniform Dutch phototherapy thresholds for preterm infants have been used nationwide, largely based on consensus. Consequently, \>80% of very preterm infants receive phototherapy for several days, accompanied by repeated blood sampling and reduced opportunities for skin-to-skin care. The corresponding UK National Institute for Health and Care Excellence (NICE) guideline applies higher (less strict) thresholds, which may reduce overtreatment, but comparative safety for very preterm infants has not been established in a randomized trial. The investigators hypothesize that using NICE thresholds is non-inferior to Dutch thresholds for survival without neurodevelopmental impairment (NDI) at two years' corrected age, while reducing treatment burden. Objective: Primary: To determine whether initiating phototherapy according to NICE thresholds is non-inferior to Dutch thresholds with regard to survival without NDI at two years' corrected age in infants born \<30 weeks of gestation. Secondary: To compare phototherapy exposure (incidence, duration and cumulative exposure) and monitoring burden (e.g., number of bilirubin blood samples, temperature instability, biomarkers of oxidative stress (subpopulation)), and to evaluate parent-infant outcomes (skin-to-skin contact time, parental stress/satisfaction), and nursing workload (time dedicated to bilirubin-related care). Study design: Nationwide multicenter, parallel-group, open-label randomized non-inferiority trial with 1:1 allocation, stratified by center and gestational age category (\<28 weeks and ≥28 weeks). Follow-up continues to the routine neurodevelopmental assessment at two years' corrected age. Planned project duration: 36 months. Study population: Very preterm infants born \<30+0 weeks of gestation, admitted to a participating Dutch NICU within 24 hours after birth. Intervention: Bilirubin monitoring and phototherapy according to one of two threshold strategies: (1) current Dutch phototherapy thresholds (control) or (2) thresholds from the UK NICE guideline (intervention). Phototherapy is delivered using standard NICU devices. Main study parameters/endpoints: Primary endpoint: survival without NDI at two years' corrected age. NDI is defined as Bayley Scales of Infant and Toddler Development, fourth Edition, Dutch Version (BSID-IV-NL) cognitive and/or motor composite score \<85 and/or hearing impairment and/or visual impairment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both strategies reflect accepted standards of care with routine bilirubin monitoring. Incremental burden consists mainly of additional registration (phototherapy use, bilirubin sampling, skin-to-skin contact, temperature instability), parental questionnaires and, in selected centers, collection of stress-related biomarkers from urine, feces, or waste material from routine blood samples to explore the physiological impact of phototherapy. No biobanking for future unspecified research is planned. The investigators will also use routinely collected and stored monitor data to assess sleep (sleep-wake states and sleep fragmentation) in a subset of infants. Neurodevelopmental follow-up at two years corrected age is routine care in Dutch NICUs. Bilirubin levels above thresholds in both groups will be mitigated by routine monitoring and management according to this study protocol. The study is group-related because bilirubin management and potential neurotoxicity thresholds are specific to very preterm infants.

Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function

This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.

White Cover & Massage Effects on Bilirubin and Phototherapy in ABO-Incompatible Newborns

This study aims to examine the effect of white cover and massage application on bilirubin levels and phototherapy duration in newborns with ABO incompatibility receiving phototherapy.

Photobiomodulation on Performance in Female Futsal Athletes

The aim of this study is to investigate the effects of photobiomodulation therapy (PBMT) on physical performance in female futsal athletes. It is hypothesized that PBMT is superior to placebo condition in improving the ability to perform repeated sprints and aerobic capacity in high-intensity, intermittent activity (i.e., Bangsbo sprint test and yoyo intermittent recovery level-1, respectively).

Photobiomodulation on Recovery in Female Futsal Athletes

The aim of this study is to investigate the effects of photobiomodulation therapy (PBMT) on recovery after high-intensity, intermittent exercises in female futsal athletes. It is hypothesized that PBMT is superior to placebo condition in improving the recovery of muscle function after high-intensity, intermittent exercises.

Healing Light Algorithms for Nurses in the ICU

The purpose of this study is to investigate the impact of a newly installed device administering a Light Scheduling Algorithm with high circadian effective irradiances to mechanically ventilated patients on the perceived stress among nursing care specialists. The investigators will further evaluate the impact on commitment to the workplace, meaning of work, and empathy.