[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newborn-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newborn-infant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,67,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100621394","effect-of-topical-oxygen-and-led-light-therapy-on-nipple-crack-100621394",false,"NCT07370051","Effect of Topical Oxygen and LED Light Therapy on Nipple Crack","Effect of Topical Oxygen and LED Light Therapy on Nipple Crack: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Individuals aged 18-40,\n* Those who gave birth at term (37-42 weeks),\n* Those whose baby was 0-28 days old at the first visit,\n* Those diagnosed with nipple fissures,\n* Breastfeeding their baby,\n* Those who have had a single birth,\n* Those without a diagnosis of psychiatric illness and who are not taking related medication.\n\nExclusion Criteria:\n\n* Those with infection, mastitis, abscess, etc. accompanying nipple injury,\n* Those who have started medical treatment for nipple injury,\n* Those who are unable to continue breastfeeding,\n* Those who feed their baby by expressing breast milk,\n* Those who show any adverse reaction to photosensitivity or exposure to sunlight.","FEMALE","18 Years","40 Years",{"count":20,"type":21},51,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nThis 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\u002Fcm², 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.\n\nTo reduce measurement and analysis bias, support will be obtained from an independent observer and a statistician.",[27,28,29,30],"Breastfeeding","Newborn Infant","Midwifery","Breast","NOT_YET_RECRUITING","2026-05-23",{"date":34,"type":35},"2026-05-27","ACTUAL",{"date":37,"type":21},"2026-09-15",{"date":39,"type":21},"2027-04-15",{"name":41,"class":42},"Istanbul University - Cerrahpasa","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100621392","the-effect-of-lullaby-during-bath-time-on-mother-infant-bonding-postpartum-depression-and-parental-self-efficacy-in-infants-100621392","NCT07370025","The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants","Inclusion Criteria:\n\n* Mothers who have had an uncomplicated pregnancy and delivery\n* Mothers who are healthy enough to care for their baby\n* Mothers who have suitable conditions at home to bathe their baby\n* Babies born at term (≥ 37 weeks of gestation) and with stable general health after birth\n\nExclusion Criteria:\n\n* Mothers with a history of serious postpartum complications (such as postpartum hemorrhage)\n* Mothers diagnosed with psychiatric illness\n* Mothers who are unable to participate directly in the care of their baby (due to severe disability, mandatory bed rest, etc.)\n* Mothers who cannot participate in the lullaby program due to hearing impairment\n* Infants who experience serious respiratory, cardiac, or neurological problems at birth or thereafter, who have a skin disease or dermatological condition that limits bathing, who have a history of admission to the neonatal intensive care unit, or who have a chronic disease or congenital anomaly",true,{"count":52,"type":21},98,[24],"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.\n\nThe 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.\n\nOutcome 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.\n\nThe 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.",[28,56,57,58],"Bonding","Self Efficacy","Postpartum Depression (PPD)","2026-01-28",{"date":61,"type":35},"2026-01-30",{"date":63,"type":21},"2026-05-15",{"date":65,"type":21},"2027-01-15",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":50,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":43},"100617272","birth-cohort-development-of-ige-autoantibodies-in-newborns-with-high-risk-of-atopic-dermatitis-100617272","NCT07316465","Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis","Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort","DIANA","Inclusion Criteria:\n\nNewborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:\n\n* 400 newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n* 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n\nExclusion Criteria:\n\n* Newborns not born at the maternity ward of UZ Brussel\n* Parents with a poor understanding of Dutch, French or English\n* Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \\\u003C34 weeks) or with medical complications\n* Newborns with severe genetic abnormalities\u002Fbirth defects\n* Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)","ALL","1 Hour","24 Months",{"count":79,"type":21},500,[24],"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.\n\nThis 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.\n\nThe 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.\n\nThis 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\u002For serve as predictive factors for the development of atopic eczema.",[83,84,85,86,87,88,28],"Atopic Dermatitis (AD)","Autoantibody","Auto-Immunity","Microbiome, Human","Allergic Disease","IgE-Mediated Hypersensitivity",[90,91,92,93,73],"Birth cohort","Autoantibodies","IgE","Atopic dermatitis","RECRUITING","2025-12-18",{"date":97,"type":35},"2026-01-05",{"date":99,"type":35},"2023-10-01",{"date":101,"type":21},"2030-12-31",{"name":103,"class":42},"Universitair Ziekenhuis Brussel",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":50,"sex":75,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":43},"100613270","impact-of-physical-activity-during-pregnancy-on-cardiac-variability-in-newborns-100613270","NCT07264400","Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns","NEOMOUV","Inclusion Criteria:\n\n* All newborns of mothers who participated in the PregMouv study and who have at least one piece of data for the main criterion from the PregMouv study (physical activity at T1\u002FT2),\n* born at the Clermont Ferrand University Hospital and after parental agreement for their child to participate may be included.\n\nExclusion Criteria:\n\n* Newborns requiring aminergic support in the first days of life,\n* making heart rate variability analysis impossible,\n* having received invasive ventilatory support that does not allow analysis of the oximetry recording.\n* Parental refusal or inability of parents to give their consent for their child to participate.","1 Day","3 Days",{"count":114,"type":21},100,[24],"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.",[28],[119,120],"heart rate variability","oximetry","2025-12-02",{"date":123,"type":35},"2025-12-04",{"date":125,"type":35},"2025-10-15",{"date":127,"type":21},"2029-04",{"name":129,"class":42},"University Hospital, Clermont-Ferrand"]