Clinical trials: sponsored by Fudan University
Neonatal Congenital Heart Disease
Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
This is a prospective observational screening study. First, researchers will optimize a two-indicator screening protocol for neonatal congenital heart disease (NCHD) adapted to high-altitude regions and evaluate its screening…
- Trial name
- NCT07901998
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Puberty Changes
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
1. Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type.
- Trial name
- NCT06820931
- Testing
- Xuandi Ziyin Mixture
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Children's Hospital of Fudan University
Sepsis, Blood Purification
Blood Purification in Septic Children
In septic shock, dysregulated host responses to pathogens lead to cytokine storms that damage host tissues and organs, further contributing to the development of organ dysfunction and increased mortality.
- Trial name
- NCT05595239
- Testing
- blood purification(CVVH), blood purification(TPE+CVVH), blood purification(HP+CVVH)
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Children's Hospital of Fudan University
Infections
A Cohort Study on Anti-microbial Stewardship in PICU
Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality.
- Trial name
- NCT05862688
- Testing
- antimicrobial therapy
- Volunteers
- 1,000 people
- Sponsor
- Children's Hospital of Fudan University
VAP - Ventilator Associated Pneumonia
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP（Ventilator-associated pneumonia）is the most common complication of mechanical ventilation in severely ill patients. VAP is defined as pneumonia occurring 48 hours after patients receive mechanical ventilation, including…
- Trial name
- NCT04955821
- Testing
- mNGS diagnose of VAP
- Volunteers
- 400 people
- Sponsor
- Children's Hospital of Fudan University
Premature Infant
A Study of Family-integrated Care for Reducing Uncertainty
To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different…
- Trial name
- NCT04648787
- Testing
- family-integrated care, traditional nursing
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Children's Hospital of Fudan University
Beta-Thalassemia
A Long-term Follow-up Study in Participants Who Received CS-101
This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189)
- Trial name
- NCT06479616
- Testing
- CS-101
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Children's Hospital of Fudan University
Intervention
Effect of Developmental Care on Very Low Birth Weight Infants
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are: Does developmental care shorten the length of hospital stay in…
- Trial name
- NCT06515574
- Testing
- developmental care
- Where
- 2 sites in China
- Volunteers
- 1,600 people
- Sponsor
- Children's Hospital of Fudan University
Congenital Heart Disease, Acute Kidney Injury
Effects of Anesthetic Techniques on Renal Function
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.
- Trial name
- NCT04030481
- Testing
- inhalation anesthesia, Total intravenous anesthesia
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Autism Spectrum Disorder, Therapy
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
The project aims to develop and implement the Strategies for Toddler Autism spectrum disorder(ASD) with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai.
- Trial name
- NCT05901558
- Testing
- Strategies for Toddler ASD with Remote-therapy (STAR), Community intervention
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Children's Hospital of Fudan University
Kawasaki Disease
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .
- Trial name
- NCT07686770
- Testing
- IVIG, Aspirin, Firsekibart
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Children's Hospital of Fudan University
Mindfulness Skills, Psychosocial Education
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
This is a single-center, randomized, controlled intervention study designed to evaluate the effectiveness of mindfulness intervention on reducing body-focused repetitive behaviors (BFRBs) in children aged 8-18, such as…
- Trial name
- MIND-BFRB (NCT06777212)
- Testing
- Mindfulness Training Program, Psychosocial Education Program
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Kawasaki Disease, Pilot Study
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was…
- Conditions
- Kawasaki Disease, Pilot Study, Coronary Artery Aneurysm, Rivaroxaban
- Trial name
- NCT06978439
- Testing
- Rivaroxaban (Xarelto)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Fudan University
Autism
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
This randomized controlled trial aims to evaluate the efficacy of a 3-month maternal interactive massage intervention in toddlers aged 18-24 months with autism spectrum disorder (ASD).
- Trial name
- IMI-ASD (NCT07876245)
- Testing
- Maternal Interactive Massage, Behavioral
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Autism, Intervention (Training) Condition
Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum…
- Conditions
- Autism, Intervention (Training) Condition, Social Cognition, Cognition Improvement
- Trial name
- PMSC-ASD (NCT07708246)
- Testing
- Companion Mind-Drawing Cooperative Game Program
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Emmetropization, Myopia
Focus-out Glasses on Emmetropization in Chinese Children
The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.
- Conditions
- Emmetropization, Myopia, Hyperopia
- Trial name
- NCT05689567
- Testing
- DEFOG glasses(peripheral focus-out glasses)
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Physical Functional Impairment, Cognitive Impairment
PICS-p Longitudinal Cohort Study
Children who survive critical illness may develop new or worsening problems with physical health, cognitive status, emotional well-being, and social functioning.
- Conditions
- Physical Functional Impairment, Cognitive Impairment, Psychological Distress, Impaired Social Functioning
- Trial name
- PICSpLCS (NCT07876271)
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
RSV Immunization
Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China
The goal of this clinical trial is to evaluate whether an AI-assisted primary care intervention for parents can increase RSV monoclonal antibody (mAb) uptake among infants, and to assess the cost-effectiveness and potential for…
- Trial name
- NCT07856290
- Testing
- RSV AI-assisted primary care intervention
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Fudan University
Cardiovascular Syndrome, Metabolic
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with…
- Trial name
- NCT06500078
- Testing
- Intermittent dietary restriction, General health education
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Children's Hospital of Fudan University
Penile Cancer
A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer
Penile cancer is a rare malignant tumor of the male genitourinary system, with 95% being squamous cell carcinoma. Due to social factors, delayed diagnosis is common, leading to a high rate of lymph node metastasis (17%-45% at…
- Trial name
- NCT07497919
- Testing
- Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Fudan University