[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07049900":3,"trial-entities:NCT07049900":90,"trial-summary:NCT07049900":94},{"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":15,"conditions":17,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":64,"locations":66,"central_contacts":81,"overall_officials":84,"references":88,"see_also_links":89},"NCT07049900","PEDS-2025-33787","Baby ABS (Abdominal Binder Study)","Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support","RECRUITING","2027-02-28","2025-09","2025-09-26","2025-09-22","University of Minnesota","OTHER",null,"The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.",[18,19,20,21],"Premature","Premature Lungs","Ventilator Lung; Newborn","Rectus Abdominis",[23,24,25],"bCPAP","CPAP","NAVA CPAP","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},40,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","NeoBelly Band","The DandleLion NeoBellyBand (NBB) is an FDA listed Class 1 medical device that is 510k exempt and is categorized under therapeutic medical binders. This device is indicated to be used while the infant is receiving CPAP support in order to reduce CBS. The NBB is made of a medical-grade blend of fabric and foam that is latex and neoprene-free and is reported as safe to use on premature infant skin. There are two sizes available and the outer fabric is attached with adjustable Velcro. It is a single baby use and may be hand washed and reused. This device is currently in use in multiple NICUs around the country, and as it has already been FDA-approved for the purpose of our investigation.",[39],"NeoBelllyBand",[41],{"measure":42,"description":43,"timeFrame":44},"Change in thickness of the rectus abdominis muscle","Thickness measured by ultrasound","8 weeks",[],"ALL","26 Weeks","31 Weeks",false,{"inclusion":51,"exclusion":54,"raw_text":63},[52,53],"Premature viable neonates with corrected gestational age of 26-31 weeks","Anticipated to require non-invasive continuous positive pressure ventilation including bCPAP, CPAP, and NAVA CPAP for a minimum of 2 weeks either on their first trial of CPAP or after extubation.",[55,56,57,58,59,60,61,62],"Outside of gestational age at birth","Umbilical lines","Genetic condition or neuromuscular anomaly","Known abdominal anomaly","Non-viable neonates and neonates with uncertain viability who are not anticipated to be able to survive with standard NICU care.","Surgical intervention on the abdominal wall, such as gastroschisis or history of surgical NEC","Compromised skin integrity of abdominal wall","Any condition in the opinion of the investigator that would risk the data integrity or collection of the study","Inclusion Criteria:\n\n* Premature viable neonates with corrected gestational age of 26-31 weeks\n* Anticipated to require non-invasive continuous positive pressure ventilation including bCPAP, CPAP, and NAVA CPAP for a minimum of 2 weeks either on their first trial of CPAP or after extubation.\n\nExclusion Criteria:\n\n* Outside of gestational age at birth\n* Umbilical lines\n* Genetic condition or neuromuscular anomaly\n* Known abdominal anomaly\n* Non-viable neonates and neonates with uncertain viability who are not anticipated to be able to survive with standard NICU care.\n* Surgical intervention on the abdominal wall, such as gastroschisis or history of surgical NEC\n* Compromised skin integrity of abdominal wall\n* Any condition in the opinion of the investigator that would risk the data integrity or collection of the study",[65],"CHILD",[67],{"facility":13,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Minneapolis","Minnesota","55455","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Andrea Charara, MD","CONTACT","612-626-0644","chara061@umn.edu",{"lat":79,"lon":80},44.97997,-93.26384,[82],{"name":74,"role":75,"phone":83,"email":77},"(612) 626-0644",[85],{"name":86,"affiliation":13,"role":87},"Sarah Ramel, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Preterm Birth",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This interventional study plans to enroll 40 premature babies. The phase of the study is not specified.","completed","Baby ABS (Abdominal Binder Study) for Premature Babies","This study, called Baby ABS, is looking at whether using the DandleLion NeoBellyBand can help premature babies who need breathing support. The NeoBellyBand is an FDA-listed medical device. Researchers want to see if using this band increases the thickness of a muscle in the baby's belly (rectus abdominis muscle). The goal is to help these babies start eating by mouth sooner. The study is for premature babies born between 26 and 31 weeks gestational age who are expected to need breathing support (CPAP) for at least two weeks. The study plans to enroll 40 babies, but its current status is unclear.","The primary measurement for this study is taken at 8 weeks.",101,"The study will measure the thickness of the rectus abdominis muscle at 8 weeks. Babies will use the NeoBellyBand while receiving CPAP support.","Not stated in the trial record.",[],"v2"]