Clinical trials: sponsored by University of Cincinnati
Necrotizing Enterocolitis
RIC-NEC Randomized Controlled Trial
Necrotizing enterocolitis (NEC) is a serious intestinal disease of preterm and term neonates which remains a major cause of intestinal failure, and an unsolved clinical challenge in pediatrics.
- Trial name
- RIC-NEC (NCT05279664)
- Testing
- Remote ischemic conditioning (RIC) + Standard of Care for NEC, Standard of Care for NEC
- Where
- 4 sites in United States, Canada
- Volunteers
- 86 people
- Sponsor
- The Hospital for Sick Children
Down Syndrome, ADHD
Evaluating Treatment of ADHD in Children With Down Syndrome
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children.
- Trial name
- TEAM-DS (NCT04219280)
- Testing
- Quillivant XR
- Where
- 4 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Sepsis
Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's…
- Trial name
- NCT05311046
- Testing
- Pediatric sepsis screening tool (either algorithmic or manual)
- Where
- United States
- Volunteers
- 12,961 people
- Sponsor
- Computer Technology Associates, Inc.
Late-Onset Neonatal Sepsis
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no…
- Trial name
- NCT04842786
- Testing
- Coconut oil
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
International PPB/DICER1 Registry
PPB has strong genetic implications, with a unique set of conditions in an individual or their family, occurring mostly in childhood and adolescence.
- Conditions
- Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor, DICER1 Syndrome, Cystic Nephroma
- Trial name
- NCT03382158
- Where
- United States
- Volunteers
- 3,400 people, healthy volunteers welcome
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
The goal of this clinical trial is to learn whether taking oral tranexamic acid (TXA) for one week after anterior cruciate ligament (ACL) reconstruction improves recovery in adolescents and young adults aged 14 to 25 years.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Pain, Postoperative
- Trial name
- NCT07880743
- Testing
- Tranexamic Acid
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Dave Bernholt
HIV Infections
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department…
- Trial name
- Screen Smart (NCT06003192)
- Testing
- Universal Opt-out HIV Screening
- Where
- 4 sites in United States
- Volunteers
- 63,000 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
ADHD, Autism Spectrum Disorder
AWARE: Management of ADHD in Autism Spectrum Disorder
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism.
- Trial name
- NCT05916339
- Testing
- Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
- Where
- 13 sites in United States, Canada
- Volunteers
- 500 people
- Sponsor
- Daniel Coury
Genetic Screening, Adolescent
Engaging Adolescents in Decisions About Return of Genomic Research Results
Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a…
- Conditions
- Genetic Screening, Adolescent, Genetic Change, Shared Decision Making
- Trial name
- NCT04481061
- Testing
- Electronic Decision Tool
- Where
- 2 sites in United States
- Volunteers
- 787 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Autism Spectrum Disorder, Emotion Regulation
DOD Regulating Together Intervention
Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.
- Trial name
- NCT05803369
- Testing
- Regulating Together (RT), Achieving Independence and Mastery in School (AIMS)
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Crohn Disease
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both.
- Trial name
- CAMEO (NCT05781152)
- Testing
- Anti-TNF therapy
- Where
- 26 sites in United States, Canada
- Volunteers
- 1,270 people
- Sponsor
- Connecticut Children's Medical Center
Ras/MAPK Pathway Vascular Anomalies, Vascular Anomalies
24VA021; VATCH Trametinib for Ras/MAPK Pathway VAs
The purpose of this study is to assess the effectiveness and safety of Trametinib (the "Study Drug") in patients with Ras/MAPK pathway driven vascular anomalies (VA). Trametinib has been approved by the U.S.
- Conditions
- Ras/MAPK Pathway Vascular Anomalies, Vascular Anomalies, Vascular Anomaly
- Trial name
- VATCH (NCT07549646)
- Testing
- Trametinib
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Children's Hospital of Philadelphia
Vascular Anomalies, Vascular Anomaly
24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs
The study will enroll participants 2 months of age up to 30 years of age. The purpose of this study is to assess the effectiveness and safety of Alpelisib (the "Study Drug") in patients with PIK3CA/TIE-2/TEK pathway driven…
- Conditions
- Vascular Anomalies, Vascular Anomaly, TIE2/PIK3CA Pathway Driven Vascular Anomalies
- Trial name
- VATCH (NCT07543822)
- Testing
- alpelisib (BYL719)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Children's Hospital of Philadelphia
Rheumatic Heart Disease in Children
Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease
The goal of this clinical trial is to test the effectiveness and implementation of enhanced Secondary Antibiotic Prophylaxis (SAP) supports using a hybrid type 1 effectiveness-implementation design.
- Trial name
- SHIELD 3 Adapt (NCT07666048)
- Testing
- CHW Delivered SAP Adherence Supports
- Where
- United States
- Volunteers
- 308 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Cystic Fibrosis
Hyperpolarized Imaging for New Treatments
The introduction of triple combination CFTR modulator therapy for patients with Cystic Fibrosis (CF) with at least one copy of the deltaF508 mutation is expected to provide major health benefits, but will also require novel…
- Trial name
- HyPOINT (NCT04259970)
- Testing
- Initiation of CFTR Modulator
- Where
- 4 sites in United States, Canada
- Volunteers
- 47 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Down Syndrome, Obstructive Sleep Apnea
Down Syndrome Obstructive Sleep Apnea
The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe…
- Trial name
- DOSA (NCT06043440)
- Testing
- Oxygen
- Where
- 7 sites in United States
- Volunteers
- 230 people
- Sponsor
- Brigham and Women's Hospital
Mild Hypoxic Ischemic Encephalopathy of Newborn
Cool Prime Comparative Effectiveness Study for Mild HIE
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family.
- Trial name
- COOLPRIME (NCT04621279)
- Testing
- Normothermia, Whole body therapeutic hypothermia
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- University of Texas Southwestern Medical Center
Cancer, Medication Adherence
A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer
The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications.
- Trial name
- NCT07223463
- Testing
- Tailored Program, Feedback Program (Uniform Standard of Care)
- Where
- 4 sites in United States
- Volunteers
- 160 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Cystic Fibrosis
BEGIN Novel ImagiNG Biomarkers
To determine the treatment effect of triple-combination therapy in 6-8 year olds after presumed FDA approval, using rapid structural and functional pulmonary and abdominal MRI (UTE and 129Xe).
- Trial name
- BEGINNING (NCT05517655)
- Testing
- 129Xe
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Food Allergy, Eosinophilic Esophagitis
Molecular Basis of Food Allergy
The Study examines the molecular basis of food allergy. It explores the interaction between T cells, InKT cells, basophils and cytokines in the development of food allergy.
- Trial name
- NCT01832324
- Where
- United States
- Volunteers
- 5,300 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia