Clinical Research Directory

Effect of Topical Oxygen and LED Light Therapy on Nipple Crack

The World Health Organization and UNICEF define the protection and support of breastfeeding as one of the key determinants of maternal and newborn health. Nipple cracks are common in the postpartum period and cause breastfeeding problems. If not addressed early, they can lead to interrupted or complete cessation of breastfeeding. It is important to develop methods for effective, safe, and mother-friendly care of nipple cracks. Various care approaches, such as lanolin, natural products, and hydrogels, have been described in the literature. However, evidence for non-invasive agents that support wound healing at the cellular level is limited. Evidence for LED light application is limited, and there is no evidence regarding the effect of topical oxygen application on nipple cracks. This project is designed as a randomized controlled trial to investigate the effect of topical oxygen and LED light therapy applied to nipple cracks on wound healing, pain, and breastfeeding success. The study will be conducted at the Lactation Unit of Istanbul Haseki Training and Research Hospital, Ministry of Health, between March and December 2026. The sample size was calculated using the G\*Power program; with an effect size of 0.20, a significance level of 5%, and a power of 80%, a total of 51 mothers will be included in the study. Participants will be divided into three groups using the block randomization method: Topical Oxygen (n=17), LED Light Therapy (n=17), and Control (n=17). Standard breastfeeding counseling will be provided to all groups. In addition to the intervention groups, topical oxygen will be applied at a flow rate of 10 liters per minute for 20 minutes; LED light therapy will be applied at 630 nm red and 850 nm infrared wavelengths, at an energy dose of 15.3 J/cm², for 5 minutes. Interventions will be performed on days 0, 3, and 7. Data will be collected using a personal information form, wound size measurement, Nipple Trauma Score, Visual Analog Scale, and LATCH score. The validity and reliability of the Nipple Trauma Score in Turkish will be assessed within the scope of the project. To reduce measurement and analysis bias, support will be obtained from an independent observer and a statistician.

The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants

This randomized, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. The postpartum period represents a critical phase for maternal psychological adjustment, during which stress, depressive symptoms, and low parenting confidence may negatively affect the quality of mother-infant interaction and bonding. Low-cost, culturally meaningful, and non-pharmacological interventions that support maternal well-being and early bonding are therefore of particular importance. The study will be conducted with mothers who have delivered healthy term infants in a public hospital. Eligible participants will be randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive a structured bathing education and will be instructed to bathe their infants three times per week for two consecutive weeks while singing a lullaby using their own voice in a calm and quiet home environment. Live-recorded music will not be used. The intervention emphasizes sensory interaction, emotional closeness, and maternal voice as key components. Each bathing session is expected to last approximately 10-15 minutes. The control group will receive routine postpartum care without a structured lullaby-based bathing intervention. Outcome measures include mother-infant bonding, postpartum depressive symptoms, and perceived maternal parenting self-efficacy. Data will be collected at two time points: prior to hospital discharge (within the first 24 hours postpartum) and at the end of the two-week intervention period. Validated self-report instruments will be used for all outcome assessments. The findings of this study are expected to provide evidence on the effectiveness of a simple, culturally embedded caregiving practice in supporting maternal mental health, strengthening mother-infant bonding, and enhancing parenting confidence during the early postpartum period. Results may inform postpartum care practices, parental counseling programs, and midwife-led supportive interventions.

Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis

Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as "self-reactive antibodies" or "autoantibodies". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate. This study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema. The study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months. This study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and/or serve as predictive factors for the development of atopic eczema.

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

Ancillary study of the PregMouv study which aims to evaluate an intervention allowing the best adherence of women in terms of physical activity. Several types of interventions are therefore planned in this study: no intervention, physical activity sessions in person, by videoconference or mixed (in person and videoconference) with accelerometer assessment of the level of physical activity practiced (in the form of energy expenditure, in MET). Thus, for our ancillary study, a comparison of the cardiac variability of newborns will be carried out according to the level of physical activity practiced by the mother regardless of the intervention she benefited from within the framework of the PregMouv study. A comparison of the average saturation and the time spent below 90% saturation will be carried out via a continuous recording of saturation by oximetry. A longitudinal follow-up for the assessment of height and weight growth (from growth curves) and neurodevelopment (by clinical examination and self-questionnaire) is also planned until the child is 2 years old.