Clinical Research Directory

ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU

This randomized controlled trial will evaluate two Acceptance and Commitment Therapy (ACT)-based counseling approaches for mothers whose infants are hospitalized in a Neonatal Intensive Care Unit (NICU). Mothers of infants in the NICU may experience high levels of stress, anxiety, and depressive symptoms. ACT is an approach that aims to improve psychological flexibility by helping people respond more effectively to difficult thoughts, emotions, and stressful experiences. A total of 135 mothers will be enrolled from two hospitals in Istanbul, Türkiye. Participants will be randomly assigned to one of three groups: an individual online ACT-based workshop, an ACT-based chatbot counseling program, or standard care. Mothers in the online workshop group will receive one individual 60-minute online session that includes mindfulness, acceptance, cognitive defusion, values clarification, and committed action exercises. Mothers in the chatbot group will receive ACT-based psychoeducation, guided exercises, and supportive digital counseling through a mobile application for four weeks. Mothers in the control group will receive the routine information and care normally provided in the NICU. Psychological flexibility will be the primary outcome. Depression, anxiety, and stress symptoms will be evaluated as secondary outcomes. Assessments will be completed at baseline, Week 2, Week 4, and at the 6-month follow-up. The study aims to determine whether ACT-based online and digital counseling can improve psychological flexibility and reduce psychological distress among mothers of infants hospitalized in the NICU.

The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns

Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications. This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age). A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier). Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator. Physiological impact (heart rate, oxygen saturation) and propagation time were recorded. The findings provide evidence for safe and effective non-pharmacological interventions in pain management and their inclusion in developmental care protocols.

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.

Pasteurised Donor Human Milk Supplementation for Term Babies

PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.

Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT

The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability. It supports the practice of clustered care, which refers to grouping routine medical and nursing procedures into a single care time period to reduce handling and allow the infant uninterrupted rest and maintenance of the sleep-wake cycle. This study aims to develop a clustered care practice guideline and evaluate its effectiveness. The study was designed as a single-blind randomized controlled trial, where the participating nurses will not be informed about their group allocation (intervention or control) to reduce bias.The study will be conducted between July and September 2025 in the level 2 and 3 NICUs of Necmettin Erbakan University Faculty of Medicine Hospital in Konya, Turkey. The study population includes all 44 nurses working in these NICUs who meet the inclusion criteria and agree to participate. Since the entire population is accessible, total population sampling will be used. After data collection is completed, a post hoc power analysis will be conducted using G\*Power (v3.1.9.2). Data will be collected using the "Descriptive Information Form for the Infant and the Nurse" and the "Clustered Care Practice Guideline". Pre-test data will be collected before training, and post-test data will be collected 4-6 weeks after the training. The intervention group will receive the Clustered Care Practice Training Based on Individualized Developmental Care in two in-person sessions (approx. 45 minutes per session), delivered in small groups (11-12 participants). A training booklet prepared by the researchers will be distributed at the end of the sessions. The normality of the data will be assessed using the Kolmogorov-Smirnov test, normal distribution curves, and skewness-kurtosis values. Parametric tests will be used for normally distributed data; non-parametric tests will be used otherwise. A significance level of P\<0.05 will be applied. Ethical approval was obtained from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research (decision no: 2022/014, date: 21.06.2022). Institutional permission was obtained from NEU Faculty of Medicine Hospital. Written informed consent will be obtained from all participating nurses and from parents of the observed infants.

Maternal Sensory Interventions in Newborns

This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.

Reducing Fluids Intakes in Neonatal Intensive Care

During stay in the neonatal intensive care unit, newborns requires various treatments administered intravenously. The hidden fluid intake associated with these infusion can lead to fluid overlad, increasing the risk of complications.This study aims to describe the variation of hidden fluid intake associated with treatment infusion, develop a new care protocol for the administration of intravenous medication in the neonatal intensive care unit, and finally standardize care practices related to the infusion of medication to improve the safety and quality of care for newborns.

Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques. This project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.