Clinical trials: Neurodevelopmental Disorders
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Autism Spectrum Disorder
How Simplified Language Affects Comprehension and Learning in Young Autistic Children
The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD.
- Trial name
- PALS (NCT05707923)
- Testing
- Linguistic simplification
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- Michigan State University
Rett Syndrome
A Novel, Regulated Gene Therapy (NGN-401) Study for Females With Rett Syndrome
This study will evaluate the efficacy and safety profiles of the investigational gene therapy, NGN-401, in females with typical Rett syndrome.
- Trial name
- NCT05898620
- Testing
- NGN-401
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 33 people
- Sponsor
- Neurogene Inc.
Jordan's Syndrome, PPP2R5D Neurodevelopmental Disorder
Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])
The primary objective of this study is to assess the efficacy, safety, and tolerability of BPN14770 in participants aged 9 to 45 years with JS.
- Trial name
- NCT06717438
- Testing
- BPN14770
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Shionogi
Depression, Adolescent Development
Thoughts and Health - Preventing Depression in Adolescents
This study aims to test the feasibility of implementing an Icelandic cognitive-behavioral program designed to prevent depression, called "Thoughts and Health" in a Swedish school setting.
- Conditions
- Depression, Adolescent Development, Mental Disorder, Child
- Trial name
- NCT04128644
- Testing
- Thoughts & health, Treatment as Usual
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Vastra Gotaland Region
Premature Birth, Neurodevelopmental Disorders
Probiotics Supplementation for Neurodevelopment in Preterm Infants
The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure.
- Conditions
- Premature Birth, Neurodevelopmental Disorders, Dysbiosis
- Trial name
- NCT07617181
- Testing
- Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
Newborn, Infant, Disease, Neurodevelopmental Disorders
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty
Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal…
- Trial name
- miniNO-COVID (NCT04952870)
- Testing
- Inhaled NO, routine care
- Where
- 2 sites in France, Greece
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille
High Risk Infant, Neurodevelopmental Disorder (Diagnosis)
SAFE Early Intervention for At-Risk Infants
This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months.
- Conditions
- High Risk Infant, Neurodevelopmental Disorder (Diagnosis), Preterm
- Trial name
- SAFE-EFFECT (NCT07596147)
- Testing
- SAFE Early Intervention Program, NDT TREATMENT
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people
- Sponsor
- Gazi University
Autism, Autism Spectrum Disorder
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Trial name
- NCT07590973
- Testing
- BlinkLab Dx1, Retrospective Neurodevelopmental Diagnostic Assessment
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Blinklab Limited
Congenital Heart Disease
Neurodevelopmental Disorders in Children With Congenital Heart Disease
Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society.
- Trial name
- NeuroDis-CHD (NCT03360370)
- Testing
- Ages & Stages Questionnaires, Third Edition in French (ASQ-3™)
- Where
- France
- Volunteers
- 233 people
- Sponsor
- University Hospital, Lille
Aicardi Syndrome, Brain Disorders
Study of Selected X-Linked Disorders: Aicardi Syndrome
Based on our current understanding of Aicardi syndrome, the condition is hypothesized to occur due to a genetic change on the X-chromosome.
- Trial name
- NCT00697411
- Testing
- Syndrome cause identification
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Baylor College of Medicine
Neurodevelopmental Disorders With Severe Self-injuries
Efficacy of Cannabidiol in the Management of Self-injuries in Children and Adolescents With Severe Neurodevelopmental Disorders.
Self-injuries includes repetitive actions directed at oneself, such as biting, hitting, hitting one's head or limbs, slapping oneself, pulling one's hair, or hitting oneself in the eyes, which can lead to severe injury.
- Trial name
- CBD-SIB (NCT07564245)
- Testing
- Cannabidiol
- Where
- 2 sites in France
- Volunteers
- 21 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Irritability, Neurodevelopmental Disorders
A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)
The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged…
- Conditions
- Irritability, Neurodevelopmental Disorders, Impulsivity, Emotional Dysregulation
- Trial name
- AGENCIA (NCT07560072)
- Testing
- AGENCIA Digital Self-Guided, AGENCIA In-person With Digital Assistant
- Where
- Spain
- Volunteers
- 465 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Neurodevelopmental Disorders, Neurodevelopmental Disorders and Developmental Abnormalities
Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders
The purpose of this clinical trial is to evaluate whether the COPCA® program (Coping with and Caring for Infants with Special Needs) is more effective than conventional pediatric physiotherapy and parent education in improving…
- Trial name
- COPCA (NCT07387627)
- Testing
- Coping with and Caring for Infants with Special Needs, Parental Education Program, Conventional Pediatric Physiotherapy
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- University of Seville
Neurodevelopmental Disorders, Congenital Cardiomyopathy
KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%.
- Trial name
- KHB (NCT05658965)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Lille
Neurodevelopmental Disorder (Diagnosis)
Transdiagnostic Dimensional Profiling of Neurodevelopmental Disorders
In recent years, the growing awareness of the multifactorial nature of neurodevelopmental disorders has stimulated interest in transdiagnostic approaches aimed at investigating underlying etiological mechanisms beyond traditional…
- Trial name
- RDoC-CRAB (NCT07544199)
- Testing
- Neuropsychological assessment
- Volunteers
- 300 people
- Sponsor
- IRCCS Eugenio Medea
Autism Spectrum Disorder, Other Neurodevelopmental Disorder
Early Assessment of Autism Through Smart Tablet Gameplay
The primary aim of this study is to compare the diagnostic accuracy of an iPad application (Play.Care assessment) with the current clinical "gold standard" diagnosis for diagnosis of Autism Spectrum Disorder (ASD) in children.
- Trial name
- NCT03438994
- Testing
- Play.Care
- Where
- 2 sites in Sweden, United Kingdom
- Volunteers
- 779 people, healthy volunteers welcome
- Sponsor
- University of Strathclyde
Neurodevelopmental Disorders, Autism Spectrum Disorder
Patterns of Neurodevelopmental Disorders
The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection, Pediatric Acute-Onset Neuropsychiatric Syndrome
- Trial name
- NCT06213090
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Richard Frye
Neurodevelopmental Disorders, Autism Spectrum Disorder
Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery
In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Atypical Neurodevelopmental Disorder
- Trial name
- COGSO (NCT07439276)
- Testing
- Test, Questionnaires
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Alcohol Related Disorders, Substance Related Disorders
The Co-Venture Trial: A Cluster Randomized Trial of Personality-targeted Interventions on Adolescent Substance Use and Cognitive Outcomes
The Preventure Program is the first and only school-based alcohol and drug prevention program that has been shown to prevent onset and growth in alcohol and substance misuse in British and Canadian youth.
- Trial name
- NCT01655615
- Testing
- Preventure programme
- Where
- Canada
- Volunteers
- 3,900 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital