[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"feeding-disorder-neonatal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:feeding-disorder-neonatal":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100525204","feasibility-of-aerodigestive-stimulation-therapy-trial-100525204",false,"NCT06118697","Feasibility of Aerodigestive Stimulation Therapy Trial","Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties","FAST","Inclusion Criteria:\n\n* NICU infant ≥37 weeks postmenstrual age not taking full oral feeds\n* Consult to Neonatal \\& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered\n* Presence of peristaltic and sphincteric reflexes at initial manometry\n\nExclusion Criteria:\n\n* Potentially lethal chromosomal anomalies\n* Craniofacial malformations\n* Foregut malformations","ALL","1 Day","8 Months",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:\n\n* To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.\n* To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.\n\nParticipants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.",[28],"Feeding Disorder Neonatal",[30,31,32,33],"Chronic tube feeding","Gastrostomy","Deglutition","Esophageal manometry","RECRUITING","2026-04-29",{"date":37,"type":38},"2026-05-05","ACTUAL",{"date":40,"type":38},"2024-02-05",{"date":42,"type":22},"2028-11-01",{"name":44,"class":45},"Sudarshan Jadcherla","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":46},"100485728","probiotic-supplementation-in-extremely-preterm-infants-in-scandinavia-100485728","NCT05604846","Probiotic Supplementation in Extremely Preterm Infants in Scandinavia","Probiotic Supplementation in Extremely Preterm Infants in Scandinavia: A Double-blinded Randomized Controlled Multicenter Trial to Reduce the Risk of Necrotizing Enterocolitis and Mortality","PEPS","Inclusion Criteria:\n\n-All extremly preterm infants born beween gestational age 22+0 to 27+6\n\nExclusion Criteria:\n\n* Patients with severe complications and low chance of survival detected wihin the first 72 hours of life\n* Patients with major congenital-anomalies\n* Patients included in other interventional trials with the same or overlapping oucome measures.","22 Weeks","28 Weeks",{"count":58,"type":22},1600,[25],"The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28.\n\nP: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark.\n\nI: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34.\n\nC: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily.\n\nO: Primary outcome variables is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge.\n\nPatient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.",[62,63,64,28,65],"Necrotizing Enterocolitis","Death","Sepsis Newborn","Growth Acceleration",[67,68,69,70],"Probiotics","NEC","Extreme prematurity","Feeding tolerance","2023-10-13",{"date":73,"type":38},"2023-10-16",{"date":75,"type":38},"2022-12-16",{"date":77,"type":22},"2026-12",{"name":79,"class":80},"Region Stockholm","OTHER_GOV"]