[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-birthweight-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-birthweight-infant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,83],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100532409","feeding-tolerance-and-growth-of-preterm-infants-consuming-a-supplement-containing-two-human-milk-oligosaccharides-hmos-100532409",false,"NCT06212427","Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)","Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \\[LAR\\], if applicable)\n2. Infant's parent(s)\u002FLAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol\n3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound\n4. Infant birth weight ≤ 2500g\n5. Infant postnatal age ≤ 14 days\n6. Infant has tolerated trophic feeds (e.g., 10-15 mL\u002Fkg\u002Fday) for at least 24 hours but has not yet reached full enteral feeding\n\nExclusion Criteria:\n\n1. Infant is clinically unstable, for example:\n\n   1. Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP \\\u003C 5th percentile for age for at least three hours), or is receiving vasopressor drugs\n   2. Infant has received an exchange transfusion within the past 48 hours\n   3. Infant has had an episode of severe asphyxia at birth (PH less than 7.0)\n   4. Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)\n2. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)\n3. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study\n4. Participation in another interventional clinical study that may interfere with the results of this study","ALL","0 Days","14 Days",{"count":20,"type":21},188,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \\[2'FL\\] and lacto-N-neotetraose \\[LNnT\\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.\n\nA comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.",[27,28],"Premature Infant","Low Birthweight Infant",[30,31,32],"Human Milk Oligosaccharides","Feeding tolerance","Growth","RECRUITING","2025-12-01",{"date":36,"type":37},"2025-12-08","ACTUAL",{"date":39,"type":37},"2023-11-20",{"date":41,"type":21},"2026-02-28",{"name":43,"class":44},"Société des Produits Nestlé (SPN)","INDUSTRY",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100576643","exploring-minor-proteins-and-peptides-in-human-milk-a-proteomic-analysis-across-lactation-stages-100576643","NCT06787963","Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages","Quantitative Proteomic Analysis of Minor Whey Proteins and Peptides of Human Milk Across Five Neonatal Groups Classified by Birth Weight During the Three Stages of Lactation","PROTEOM-MILK","Inclusion Criteria:\n\n* Healthy mothers\n* With monitored pregnancies within the care area of the Reina Sofía University Hospital in Córdoba\n* With newborns expected to be exclusively breastfed until 4 months\n\nExclusion Criteria:\n\n* Mothers whose newborns have any of the following conditions: congenital malformation, chromosomal abnormality, hypoxia-ischemia, gastroschisis, polycythemia, hypoglycemia, sepsis, blood incompatibility\n* Pathological pregnancy, pregnancy by in vitro fertilization, or multiple pregnancies\n* With no plan to exclusively breastfeed until 4 months\n* Under medical treatment\n* Have a drug addiction\n* Refuse informed consent\n* Have had previous breast surgery\n* Live outside the metropolitan area",true,"120 Days",{"count":57,"type":21},150,"OBSERVATIONAL","Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants. HM contains a wide variety of minor whey proteins and peptides with important bioactive functions, many of which are still unknown. Proteomics allows for the study of biological samples with inherently complex protein mixtures. Proteins are essential for the development of living organisms, both in quantitative and qualitative terms. The combination of proteomic techniques currently enables the study of protein variability and minor peptides in HM across different lactation stages and allows for differential quantification according to gestational age and birth weight. However, studies on the human milk serum proteome during these stages are limited. The aim is to explore the minor whey proteins and peptides in human milk through a longitudinal analysis of five groups of breastfeeding mothers (with 30 extremely low birth weight newborns, 30 very low birth weight newborns, 30 low birth weight newborns, 30 adequate birth weight newborns, and 30 high birth weight newborns). Gestational age will also be considered to ensure homogeneous group distribution according to this condition. HM samples will be collected from each mother during three lactation periods after birth: within the first 48 hours (colostrum), at 5-14 days (transitional milk), and at 100-120 days (mature milk) for the five birth weight groups. In these neonatal\u002Finfant groups, minor proteins from whey fraction and peptides will be separated, quantified, and identified using label-free proteomic techniques. This study aims to expand our understanding of the minor proteins and peptides in human milk and their bioactive roles in neonatal health. By examining these components across different birth weight groups and lactation stages, the research will offer insights into how protein and peptide profiles vary by gestational age and birth weight, potentially influencing neonatal development. The findings from this proteomic analysis could not only demonstrate the complexity of human milk composition but also contribute to targeted nutritional support for preterm or low-birth-weight infants, customizing protein supplementation in HM banks and therefore enhancing their growth and developmental outcomes.",[28,61,62],"Preterm","Very Low Birth Weight Preterms",[64,65,66,67,68,69,70,71],"low birth weight","prematurity","gestational age","human milk","bioactive peptides","proteomics","lactation","whey protein","2025-01-16",{"date":74,"type":37},"2025-01-22",{"date":76,"type":37},"2024-12-02",{"date":78,"type":21},"2027-12",{"name":80,"class":81},"Maimónides Biomedical Research Institute of Córdoba","OTHER",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100572135","a-multicenter-and-prospective-study-of-screening-retinopathy-of-prematurity-in-china-100572135","NCT06729333","A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China","SChiROP","Inclusion Criteria:\n\nFrom December 2024 to May 2025, preterm infants (gestational age \\\u003C37 weeks) or low birth weight infants (birth weight \\\u003C2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.\n\nExclusion Criteria:\n\n1. Death before the first screening;\n2. Death or loss to follow-up before complete retinal vascularization;\n3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;\n4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;\n5. Poor systemic condition preventing fundus examination;\n6. History of ocular trauma or surgery (excluding treatments for ROP);\n7. Poor-quality fundus images;\n8. Other conditions deemed exclusionary by the investigators.",{"count":91,"type":21},5000,"The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.",[94,95,28],"Premature Birth of Newborn","Retinopathy of Prematurity (ROP)",[97,98,99],"retinopathy of prematurity","incidence rate","screening","NOT_YET_RECRUITING","2024-12-06",{"date":103,"type":37},"2024-12-11",{"date":105,"type":21},"2024-12-15",{"date":107,"type":21},"2026-06-14",{"name":109,"class":81},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",1]