[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"risky-baby\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:risky-baby":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100631374","synchronous-vs-asynchronous-telerehabilitation-for-high-risk-infants-100631374",false,"NCT07499843","Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants","Family-Centered Early Intervention Program Under Physiotherapist Coaching for High-Risk Infants: A Comparison of Synchronous and Asynchronous Telerehabilitation Models","Inclusion Criteria:\n\n* Gestational age ≤32 weeks and\u002For birth weight ≤1500 grams.\n* Corrected age between 6 and 9 months at the time of enrollment.\n* Referral to a pediatric neurology clinic and\u002For current follow-up by a pediatric neurologist due to developmental risk.\n* A total score of ≤73 on the Hammersmith Infant Neurological Examination (HINE) (Romeo et al., 2021; Novak et al., 2017).\n* A score ≤5th percentile on the Alberta Infant Motor Scale (AIMS) (Fuentefria et al., 2017).\n* Parental willingness to participate and signing of the \"Informed Consent Form.\"\n* Access to the minimum technological infrastructure required for telerehabilitation (smartphone, tablet, or computer with video calling capability and active internet access).\n\nExclusion Criteria:\n\n* Presence of diagnosed genetic syndromes or metabolic diseases known to directly affect neuro-motor development.\n* Major congenital malformations causing significant movement restriction or exercise intolerance.\n* History of symptomatic hypoglycemia associated with severe brain injury during the neonatal period.\n* Sensory impairments (bilateral blindness or severe bilateral hearing loss not correctable with hearing aids) that prevent participation in assessments and exercises based on visual and auditory stimuli.\n* Acute or unstable clinical conditions that preclude the safe conduct of the intervention (e.g., continuous mechanical ventilation, hemodynamic instability, uncontrolled seizures, or active acute infections).\n* Non-adherence to the study protocol, defined as missing more than 6 intervention sessions.","ALL","6 Months","9 Months",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"NA","Premature birth, low birth weight, and a history of neonatal intensive care history are significant risk factors associated with long-term neurodevelopmental adverse outcomes in infants. Family-centered early intervention programs play a critical role in minimizing the impact of these risks and optimizing developmental potential. Currently, telerehabilitation (TR) has emerged as a cost-effective solution that facilitates access to early intervention services. However, there is limited literature directly comparing the efficacy and feasibility of synchronous (real-time) and asynchronous (store-and-forward) parent coaching-based TR models specifically within the at-risk infant population.\n\nThe primary objective of this project is to comparatively examine the effects of synchronous and asynchronous TR programs on motor development levels, individualized goal attainment, and parental self-efficacy in infants aged 6-9 months (corrected age) at risk of developmental delay, against a standard home program (control group). Designed as a randomized controlled trial, the study will include 45 high-risk infants meeting the inclusion criteria, who will be randomly allocated into three groups: Synchronous TR, Asynchronous TR, and Control. In the Synchronous group, parents will receive real-time coaching via video conferencing for 12 weeks, whereas the Asynchronous group process will be managed through video analysis and delayed feedback mechanisms. The Control group will be provided with standard digital educational materials.\n\nThe primary outcome measures of the study include Goal Attainment Scaling (GAS) scores, the Parental Self-Efficacy Instrument, and the Parenting Stress Index. Secondary measures will include the Bayley Scales of Infant and Toddler Development (Bayley-IV), the Alberta Infant Motor Scale (AIMS), and the Hammersmith Infant Neurological Examination (HINE). Data will be collected at baseline (T0) and post-intervention (T1) by an assessor blinded to group allocation. The findings obtained from this study aim to demonstrate the clinical efficacy of different TR models, thereby providing guidance for the planning and dissemination of remote healthcare services for high-risk infants.",[27,28,29],"Risky Baby","Premature Birth of Newborn","Motor Delay",[31,32,33,34,35],"At-risk infant","Early intervention","Telerehabilitation","Parent coaching","Motor development","NOT_YET_RECRUITING","2026-03-25",{"date":39,"type":40},"2026-03-30","ACTUAL",{"date":42,"type":21},"2026-05-04",{"date":44,"type":21},"2027-07-04",{"name":46,"class":47},"Biruni University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100597859","are-developmentally-at-risky-babies-environmentally-disadvantaged-100597859","NCT07063966","Are Developmentally At Risky Babies Environmentally Disadvantaged?","Inclusion Criteria:\n\nInclusion Criteria (Developmentally At-Risk Infants):\n\nInfants classified as developmentally at risk\n\nAged between 7 and 18 months\n\nParental consent for participation in the study\n\nInclusion Criteria (Typically Developing Infants):\n\nAged between 7 and 18 months\n\nParental consent for participation in the study\n\nExclusion Criteria:\n\n* Infants with unstable vital signs\n\nInfants currently hospitalized",true,"7 Months","18 Months",{"count":59,"type":21},52,"OBSERVATIONAL","A study conducted on infants aged between 3 and 11 months revealed a positive relationship between the home environment and developmental outcomes. Similarly, another study found that variability in motor and cognitive development could be better explained by environmental factors and parental knowledge and practices. It has also been shown that the opportunities provided in the home environment of preterm infants may be associated with motor development and sensory processing skills. In the literature, it is generally observed that studies evaluate either term infants or both preterm and term infants together. In the present study, however, infants at developmental risk and typically developing infants will be evaluated separately.\n\nThe aim of this study is to assess whether infants at developmental risk are disadvantaged in terms of their home environment.\n\nThe hypotheses of this study are as follows:\n\nH1-1: There is a difference in environmental arrangements between typically developing infants and those at developmental risk.\n\nH1-2: There is a relationship between home environmental arrangements and motor development.\n\nH1-3: There is a relationship between home environmental arrangements and sensory profile.",[27,63,64,65],"Motor Development","Sensory Profiles","Environmental Conditions",[67,68,69,70],"risky baby","motor development","sensory profiles","environmental conditions","2025-07-03",{"date":73,"type":40},"2025-07-14",{"date":71,"type":21},{"date":76,"type":21},"2025-11-10",{"name":78,"class":47},"Abant Izzet Baysal University",3]