[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498996":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":40,"locations":50,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":44,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":44,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Gastric Followed by Jejunal Feeds","EXPERIMENTAL","Participants randomized into this group will begin with one ten-day block of nasogastric (NG) feeds followed by one ten-day block of nasojejunal (NJ, postpyloric) feeds.",[13,14],"Procedure: Gastric Feeds","Procedure: Jejunal Feeds",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B: Jejunal Followed by Gastric Feeds","Participants randomized into this group will begin with one ten-day block of nasojejunal (NJ, postpyloric) feeds followed by one ten-day block of nasogastric (NG) feeds.",[13,14],[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Gastric Feeds","The participant will receive nutrition via a nasogastric tube. Gastric feedings will be administered as bolus feeds every 3 hours over 1 hour. Infants who are deemed able to advance oral feedings via mouth during the study period will be permitted to do so, and this will be recorded.",[9,16],[26,27],"Nasogastric Feeding","NG feeds",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Jejunal Feeds","The participant will receive nutrition via a nasojejunal tube. Postpyloric feedings will be administered continuously into the jejunum. Infants who are deemed able to advance oral feedings via mouth during the study period will be permitted to do so, and this will be recorded.",[9,16],[33,34,35],"Nasojejunal Feeding","Postpyloric Feeding","NJ Feeds",[37],{"name":38,"affiliation":5,"role":39},"Jonathan Levin, MD","PRINCIPAL_INVESTIGATOR",[41,46],{"name":38,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","617-355-1900",null,"jonathan.levin@childrens.harvard.edu",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Vanessa J Young, MS","617-355-8330","vanessa.young@childrens.harvard.edu",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65],{"name":38,"role":42,"phone":66,"phoneExt":44,"email":45},"617-335-1900",{"type":39,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Jonathan Levin","Instructor of Pediatrics",[71],{"name":72,"class":6},"Beth Israel Deaconess Medical Center","100498996","randomized-controlled-crossover-trial-of-postpyloric-feedings-to-improve-pulmonary-outcomes-in-high-risk-preterm-infants-100498996",false,"NCT05777512","Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants","A Randomized Controlled Crossover Trial of Postpyloric Versus Gastric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants","Inclusion Criteria:\n\nPreterm infants born \\\u003C 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:\n\n1. Remain on either invasive ventilation or non-invasive ventilation (continuous positive airway pressure or nasal intermittent positive pressure ventilation) for minimum 48 hours at the time of study entry. The minimum support required for inclusion is CPAP \\> 5cm H2O or CPAP 5 with FiO2 \\> 21%.\n2. Have ongoing need for respiratory support due to underlying lung disease from prematurity.\n3. Are tolerating \\> 80 ml\u002Fkg\u002Fday of enteral feedings at baseline, either via nasogastric (NG) or nasojejunal (NJ) tube. Patients may be receiving gastric (NG) or postpyloric (NJ) feedings.\n\nExclusion Criteria:\n\n1. Infants who are transiently on respiratory support at the time of study entry due to another reason than underlying lung disease from prematurity; for example, recovery from a surgical intervention.\n2. Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities.\n3. Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment.\n4. Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.","ALL","0 Hours","1 Year",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"NA","The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.",[91],"Bronchopulmonary Dysplasia",[93,34,33,91,94,95],"Chronic Lung Disease of Prematurity","GERD","Gastro-esophageal Reflux","2026-06-25",{"date":98,"type":99},"2026-06-29","ACTUAL",{"date":101,"type":99},"2024-04-26",{"date":103,"type":85},"2028-02",{"name":5,"class":6},1]