[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07344714":3,"trial-entities:NCT07344714":94,"trial-summary:NCT07344714":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":35,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":59,"locations":61,"central_contacts":80,"overall_officials":83,"references":85,"see_also_links":90},"NCT07344714","24-002867","Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting","Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting","RECRUITING","2026-12-31","2026-03","2026-03-18","2026-03-11","Mayo Clinic","OTHER",false,"The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (\\>6 hours of life).","The source of the gastric aspirates will be the medical waste generated through the routine care of neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.",[19,20,21,22,23,24,25,26],"Respiratory Distress Syndrome, Newborn","Respiratory Distress Syndrome in Premature Infant","Transient Tachypnea of the Newborn","Meconium Aspiration Syndrome","Pneumonia Neonatal","Hyaline Membrane Disease","Pneumothorax","Respiratory Distress Neonatal",[],"OBSERVATIONAL",null,[],{"count":32,"type":33},500,"ESTIMATED",[],[36,40],{"measure":37,"description":38,"timeFrame":39},"Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.","Calculated sensitivity, specificity, positive- and negative-predictive values of the predicted outcomes compared to actual patient outcomes.","1 years",{"measure":41,"description":42,"timeFrame":43},"Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome","Total proportion of true negatives as determined by the digital point-of-care device algorithm predicting no diagnosis of Respiratory Distress Syndrome and the clinician does not diagnosis Respiratory Distress Syndrome. Reported as a calculation of # true negatives \u002F (# true negatives + # false negatives).","2 years",[],"ALL","32 Weeks","41 Weeks",true,{"inclusion":50,"exclusion":53,"raw_text":58},[51,52],"Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated","Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization.",[54,55,56,57],"Neonates with known or suspected congenital anomalies","Neonates for whom only comfort measures are planned or possible at time of delivery","Neonates whose parents actively declined the Minnesota Research Authorization.","Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.","Inclusion Criteria:\n\nBoth of the following:\n\n* Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated\n* Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization.\n\nExclusion Criteria:\n\nAny one of the following:\n\n* Neonates with known or suspected congenital anomalies\n* Neonates for whom only comfort measures are planned or possible at time of delivery\n* Neonates whose parents actively declined the Minnesota Research Authorization.\n* Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.",[60],"CHILD",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":77},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Lavonne Liedl, LRT","CONTACT","507-255-1828","liedl.lavonne@mayo.edu",{"name":75,"role":76},"William A. Carey, MD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},44.02163,-92.4699,[81],{"name":82,"role":71,"phone":72,"email":73},"Lavonne M. Liedl, LRT",[84],{"name":75,"affiliation":13,"role":76},[86],{"pmid":87,"type":88,"citation":89},"41458086","RESULT","Leigh BC, Liedl LM, Amsbaugh AL, Carey WA. Spectral analysis of gastric aspirates obtained shortly after birth predicts the need for prolonged respiratory support in neonates in a development cohort. Front Pediatr. 2025 Dec 11;13:1686794. doi: 10.3389\u002Ffped.2025.1686794. eCollection 2025.",[91],{"label":92,"url":93},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":95,"biomarkers":98},[22,96,25,97,21],"Pneumonia","Respiratory Distress Syndrome",[],{"nct_id":4,"found":48,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study with a planned enrollment of 500 neonates (newborns).","completed","Predicting Respiratory Support Needs in Newborns","This study is looking at how to predict if newborn babies will need extra breathing support for more than six hours after birth. Researchers will analyze fluid from the stomachs of newborns, which is routinely collected after delivery. The goal is to see how well this analysis can predict the need for prolonged breathing support and also how accurately it can identify babies who will *not* develop respiratory distress syndrome (breathing problems). You might be able to join if your baby is born at 32 weeks gestational age or older, and their delivery is attended by the neonatal resuscitation team. The study is currently observational, meaning researchers are just watching and collecting information, not giving any new treatments. The status of recruitment is unclear.","The study will measure the prediction of prolonged respiratory support at 1 year and the accuracy of predicting negative cases of Respiratory Distress Syndrome at 2 years.",124,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]