[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nutrition-disorder-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nutrition-disorder-infant":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,71,95,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100531997","early-dhaara-supplementation-in-growth-restricted-very-preterm-infants-a-randomized-clinical-trial-100531997",false,"NCT06207071","Early DHA\u002FARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial","Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Gestational ages between 22 0\u002F7 - 32 6\u002F7 weeks gestation\n* \\\u003C 25th centile birthweight\n\nExclusion Criteria:\n\n* Major congenital\u002Fchromosomal anomalies\n* Terminal illness in which decisions to withhold or limit support have been made",true,"ALL","24 Hours","72 Hours",{"count":21,"type":22},152,"ESTIMATED","INTERVENTIONAL",[25],"NA","Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.",[28,29,30,31],"Infant Malnutrition","Light-For-Dates With Signs of Fetal Malnutrition","Premature","Nutrition Disorder, Infant","RECRUITING","2026-06-11",{"date":35,"type":36},"2026-06-15","ACTUAL",{"date":38,"type":36},"2024-05-20",{"date":40,"type":22},"2027-04",{"name":42,"class":43},"University of Alabama at Birmingham","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100408479","role-of-body-composition-in-large-for-gestational-age-infants-lga-with-oral-feeding-difficulty-100408479","NCT04599010","Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty","Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.","Inclusion Criteria:\n\n* LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score \\> +1.0 in body composition measurement\n\nExclusion Criteria:\n\n* Infants on any respiratory support, Infants on enteral feeding duration \\> 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes\u002Fanomalies","1 Week","10 Weeks",{"count":55,"type":22},40,[25],"Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.",[59,60,31],"Body Composition","Feeding; Difficult, Newborn","2026-05-22",{"date":63,"type":36},"2026-05-27",{"date":65,"type":36},"2024-09-26",{"date":67,"type":22},"2027-12-31",{"name":69,"class":43},"Nemours Children's Clinic",2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100574807","nutritional-intervention-for-biliary-atresia-100574807","NCT06764082","Nutritional Intervention for Biliary Atresia","Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial","Inclusion Criteria:\n\n* Infants under 3 months old;\n* Children clinically diagnosed with biliary atresia and in need of Kasai surgery;\n* The patient themselves, legal representative or guardian have signed the informed consent form and are willing to actively cooperate with treatment and follow-up.\n\nExclusion Criteria:\n\n* Low birth weight infants or very low birth weight infants;\n* Complicated with life-threatening diseases of various organ systems;\n* Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance;\n* Patients who have participated in other clinical trials within the last month;\n* Any other conditions that the researcher deems unsuitable for participation in this trial.","1 Day","3 Months",{"count":81,"type":22},120,[25],"Infants with biliary atresia (Biliary atresia, BA) have an increased risk of malnutrition due to insufficient dietary intake to maintain normal growth, impaired intestinal absorption, increased metabolic rate, and damage to some liver macronutrient metabolic pathways. The medium-chain triglyceride formula (MCT) in enteral nutrition has advantages: (1) It has a fast metabolism in the liver and possesses the advantage of being an innate energy source; (2) It can share metabolic pathways with some other fatty acids (DHA, EPA), and can promote the synthesis of phospholipids, etc. Therefore, EN containing the MCT formula is regarded as an important approach to alleviate growth retardation in BA children and improve the nutritional status of patients. This study aims to observe the effect of intensified enteral feeding with a high MCT formula during the perioperative period compared to traditional oral feeding on the prognosis of children with biliary atresia. The method adopted is a prospective, two-arm, open-label, multicenter, and interventional real-world study.",[31,85],"Biliary Atresia","2025-12-15",{"date":88,"type":36},"2025-12-22",{"date":90,"type":36},"2025-02-01",{"date":92,"type":22},"2028-12-31",{"name":94,"class":43},"Tongji Hospital",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":16,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":44},"100396871","bern-birth-cohort--trajectory-of-microbiota-maturation-in-healthy-bern-infants---a-network-approach-100396871","NCT04447742","Bern Birth Cohort \u002F Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach","BeBiCo","Inclusion Criteria:\n\n* Signed informed consent.\n* Ability to understand and follow study procedures and understand informed consent\n* From week 20 of pregnancy until birth\n* General good health, i.e. absence of major severe medical\u002F surgical\u002F psychiatric condition requiring ongoing management. Minor well controlled conditions (e.g. medically controlled arterial hypertension, occupational asthma, gestational diabetes mellitus) may be present.\n* Absence of known severe embryonal pathology, expected normal pregnancy (e.g. minor conditions including twin\u002F triplet pregnancy, final pelvic position may be present)\n* Age 18-45 years.\n\nExclusion Criteria:\n\n• Participation in another clinical study interfering with study procedures.","FEMALE","18 Years","45 Years",{"count":106,"type":22},250,"OBSERVATIONAL","Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood.\n\nAims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome.\n\nMethods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps.\n\nSpecies composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content.\n\nExpected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.",[110,111,31,112,113],"Maturation of the Healthy Infant Intestinal Microbiota","Microbial Colonization","Milk Expression, Breast","Mental Health Disorder","2024-11-11",{"date":116,"type":36},"2024-11-12",{"date":118,"type":36},"2020-05-07",{"date":120,"type":22},"2035-03-03",{"name":122,"class":43},"Insel Gruppe AG, University Hospital Bern",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":16,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":44},"100553446","preemie-milk-analyser-validation-study-100553446","NCT06486194","Preemie Milk Analyser Validation Study","Analytical Validation and Clinical Testing of the Preemie System for Analysis and Calculation of Targeted Fortification of Mother's Breast Milk for Preterm Infants","Inclusion criteria Phase 1A For University Hospital Southampton (UHS) milk bank donors\n\n* Approved as a donor for the UHS milk bank through the usual process\n* Be providing milk to UHS donor milk bank For mothers of infant inpatients\n* Have an infant who is currently an inpatient in the neonatal unit, paediatric wards, paediatric cardiac ward, or paediatric intensive care unit\n* Be providing breastmilk for their preterm or term born infant\n* Have sufficient breast milk available such that providing 120ml breast milk for the study does not impact on the needs of their infant.\n\nInclusion criteria Phase 1B\n\n* Approved as a donor for the UHS milk bank through the usual process\n* Be providing milk to UHS donor milk bank\n\nExclusion criteria Phase 1A and 1B For mothers of infant inpatients\n\n\\- Mothers whose infants are inpatients and where there is a concern about adequacy of maternal milk supply to feed their infant\n\nInclusion Criteria Phase 2\n\n* Birth weight ≥1kg and \\\u003C1.8 kg (so meet the ESPGHAN criteria for breast milk fortification)\n* Be taking fully fortified enteral breast milk feeds (≥150 ml\u002Fkg\u002Fday of mothers or donor breast milk containing breast milk fortifier as per the manufacturer's instructions)\n* Tolerating fully fortified breast milk feeds≥150 ml\u002Fkg\u002Fday for 48 hours\n* No longer on parenteral nutrition.\n\nExclusion Criteria Phase 2\n\n* Infants where there is a concern about mother's supply of breast milk being insufficient to meet demands (where donor milk is not being used to make up any shortfall);\n* Known congenital metabolic disorder;\n* Infant formula fed;\n* Bilateral grade III or IV intraventricular haemorrhage;\n* Any infant who has had gastrointestinal tract surgery;\n* Refusal of consent;\n* Refusal for the use of breast milk fortifier\n* Birthweight \\\u003C1 kg","0 Days","50 Years",{"count":133,"type":22},180,[25],"This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies. This is potentially useful, as premature babies have higher nutritional requirements than babies born at term near their due date. At the moment, a nutritional supplement called breast milk fortifier is added to breast milk in standard amounts to improve its nutritional content and help premature babies grow. However, we know that each mother's breast milk is different, and varies from day to day, so each mother's milk may require more or less of such supplements in order to meet European recommendations for the nutrient intake.\n\nThe aim of this study is to first test and validate the accuracy of the Preemie device for measuring the nutritional content of mother's breast milk, using milk donated to the local donor milk bank and from mothers of babies currently on the neonatal unit. Next, once this is complete, the aim is to demonstrate it is feasible to use the Preemie device to enable fortification of mother's milk on an individualised basis for a small group of premature babies. The growth and nutrient intakes of these babies will be compared to another group who are cared for using the standard fortification approach.\n\nThe results of this study will be used to gain \"Conformité Européenne\" (CE) certification of the Preemie device and software.",[137,138,31],"Pre-Term","Breast Milk Expression","NOT_YET_RECRUITING","2024-06-26",{"date":142,"type":36},"2024-07-03",{"date":144,"type":22},"2024-07-01",{"date":146,"type":22},"2026-07-01",{"name":148,"class":43},"University Hospital Southampton NHS Foundation Trust"]