[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-infant-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-infant-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,75,99,126],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100555939","phase-4-caffeine-citrate-in-preterm-infants-at-risk-of-apnea-in-zambia-100555939",false,"NCT06518603","Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Inclusion Criteria:\n\nNewborns:\n\n1. 29 0\u002F7 to 33 6\u002F7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,\n2. On methylxanthines with plans to discontinue on methylxanthine,\n3. Off oxygen therapy for \\>48 hours at the time of evaluation for eligibility,\n4. Receiving full daily feeds,\n5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist\n6. 18+ years of age (parent)\n\nExclusion Criteria:\n\n1. Newborns with neuromuscular conditions affecting respiration,\n2. Major congenital malformations and genetic disorders,\n3. Unable to obtain parental or guardian consent","ALL","0 Days","12 Months",{"count":20,"type":21},340,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.\n\nOur research questions are:\n\n1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?\n2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?\n\nResearchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.\n\nParents of participants will:\n\n1. Administer caffeine citrate 20mg\u002Fkg\u002Fday or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge\n2. Keep a diary of symptoms and any apneic events\n3. Check in with researchers via telephone call once a week\n4. Return to clinic for infant physical examination at 28 days\n5. Return to the clinic for infant physical examination at 2 months\n\n5\\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age",[27,28,29],"Premature Infant Disease","Apnea of Prematurity","Development, Infant","RECRUITING","2026-06-18",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2026-06-17",{"date":38,"type":21},"2027-06-30",{"name":40,"class":41},"University of Alabama at Birmingham","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100574307","necrotizing-enterocolitis-and-bowel-perforation-in-very-preterm-infants---long-term-follow-up-100574307","NCT06757582","Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up","NOR-NEC","Inclusion Criteria:\n\n* Case: All Norwegian very preterm infants (gestational age (GA) \\\u003C 32 weeks) born during the 6-year period 2008-2013, diagnosed with surgical NEC or bowel perforation and surviving up to one year of age will be invited to participate as cases.\n* Controls: For each case we will invite two controls matched for important clinical characteristics (e.g. sex, GA, clinical illness score, intracranial pathology, need for oxygen at discharge etc.).\n\nExclusion Criteria:\n\n* not signing informed consent scheme","6 Years","15 Years",{"count":53,"type":21},150,"OBSERVATIONAL","Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and\u002For small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation\u002Fnecrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower.\n\nStudies looking at \"long-term prognosis\" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age. The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group. Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency may impact cognitive development, but this has not been investigated in this \"high-risk\" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for \"more high-quality studies assessing long-term follow-up\".\n\nIn this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.",[57,58,27],"Necrotizing Enterocolitis","Intestinal Perforation",[60,61,62,63,64],"necrotizing enterocolitis","bowel perforation","preterm infant","long-term follow-up","quality of life","NOT_YET_RECRUITING","2025-01-02",{"date":68,"type":34},"2025-01-03",{"date":70,"type":21},"2025-02-01",{"date":72,"type":21},"2027-08-01",{"name":74,"class":41},"University Hospital of North Norway",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":42},"100572297","does-starting-feeds-on-the-first-day-of-life-help-premature-infants-reach-full-volume-feeds-sooner-100572297","NCT06731439","Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?","Inclusion Criteria:\n\n1. All infants less than or equal to 1000 g\n2. Clinical care team in agreement with patient's participation\n3. All mothers with pregnancies with EFW close to 1000g or less.\n\nExclusion Criteria:\n\n1 congenital malformations that may affect gastro intestinal perfusion\n\n2 Clinically progressing towards imminent death\n\n3 congenital gastrointestinal obstructions\n\n4 Mothers unlikely to deliver infants ≤ 1000g\n\n5 Infant on pressors other than dopamine given at \\\u003C 5mcg\u002Fkg\u002Fmin. Dopamine is an exclusion if administered at a dose exceeding 5mcg\u002Fkg\u002Fmin.\n\n6 Mothers who are not in a sound mental state to be consented either to their critical condition, intubated, sedated, for examples\n\n7 Mothers who are critically ill where by it is felt that mom will not be able to participate in the consent","1 Minute","6 Hours",{"count":84,"type":21},248,[86],"NA","Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.",[89,27,90],"Extra Uterine Growth Restriction","VLBW - Very Low Birth Weight Infant","2024-12-09",{"date":93,"type":34},"2024-12-12",{"date":95,"type":34},"2024-06-01",{"date":38,"type":21},{"name":98,"class":41},"University of Tennessee",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100556441","the-effectiveness-of-audiovisual-intervention-100556441","NCT06525142","The Effectiveness of Audiovisual Intervention","The Effectiveness of Audiovisual Intervention on the Parent-Child Bonding, Parental Role Perception, and Well-Being in Fathers of Premature Infants","Inclusion Criteria:\n\n* father age \\> 20\n* premature infant born at 29-36 weeks\n\nExclusion Criteria:\n\n* infant failing the hearing examination\n* father and mother are not married",true,"MALE",{"count":109,"type":21},99,[86],"The objective of this clinical study is to understand the current status of parent-child bond, parenting role perception and well-being of fathers of preterm infants, and to explore the effect of audio-visual interventions on parent-child bonding, parenting role perception and well-being of fathers of preterm infants. The main questions it aims to answer are:\n\n* After intervention, whether the parent-child connection between fathers and preterm infants in the audio-visual group is higher than that in the audio-visual group and the control group\n* After the intervention, whether the father's perception of parenting role in the audio-visual group is higher than that of the vocal group and the control group\n* After intervention, whether the father's happiness in the audio-visual group is higher than that in the audio-visual group and the control group The investigators will compare the pre- and post-test methods bwtween the experimental groups and the control group. The fathers of enrolled preterm infants will fill in the structured questionnaires at the time before the intervention (Baseline data) and one month later after the intervention.",[113,114,27],"Parent-Child Relations","Premature; Infant, Light-for-dates",[116],"Parent-Child Bonding,Parental Role Perception,Well-Being","2024-07-23",{"date":119,"type":34},"2024-07-29",{"date":121,"type":21},"2024-07",{"date":123,"type":21},"2026-06-05",{"name":125,"class":41},"Chang Gung Memorial Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":42},"100535790","effects-of-confortable-environment-kangaroo-care-and-music-therapy-in-newborns-in-neonatal-intensive-care-unit-100535790","NCT06256406","Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit","Comparative Evaluation Between Preterms and Newborns Undergoing Surgery. Effectiveness of a Multimodal Sensory Intervention on Newborns and Parents' Stress","PRE-CARE","Inclusion Criteria:\n\n* newborn hospitalized in NICU\n\nExclusion Criteria:\n\n* not hospitalized in NICU,\n* intubated infants,\n* instable clinical condition","3 Years",{"count":136,"type":21},50,[86],"Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU). These strategies not only contribute to the physical well-being of the infants but also play a significant role in promoting their emotional and developmental health.",[27,140],"Newborn Morbidity",[142,143,144,145],"Newborn","Kangaroo-Mother Care Method","Music Therapy","Intensive Care Units, Neonatal","2024-02-04",{"date":148,"type":34},"2024-02-13",{"date":150,"type":34},"2022-06-20",{"date":152,"type":21},"2026-12-31",{"name":154,"class":41},"Policlinico Universitario, Catania"]