Clinical trials: Fetal Neurodevelopmental Disorder
Neurodevelopmental Disorders, Congenital Heart Disease
Altered Cerebral Growth and Development in Infants With Congenital Heart Disease
Background: Congenital heart disease (CHD) is the most frequent inborn defect with an incidence of 1 in 100 newborns per year, i.e. 800 children born in Switzerland per year.
- Conditions
- Neurodevelopmental Disorders, Congenital Heart Disease, Brain Injuries, Fetal Growth Retardation
- Trial name
- NCT04233775
- Where
- Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Children's Hospital, Zurich
HIV, AIDS
Expansion to Interdisciplinary HIV Prevention in Women
This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general…
- Conditions
- HIV, AIDS, Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder
- Trial name
- NCT01994603
- Testing
- Opt-in or Opt-out testing, Focus Group
- Where
- 2 sites in United States, Russia
- Volunteers
- 41 people
- Sponsor
- University of Oklahoma
Fetal Neurodevelopmental Disorder, Cavum Septum Pellucidum
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum
The aim of this observational study is to evaluate the incidence of the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration performed at second-trimester ultrasound, as well…
- Trial name
- NCT06782802
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Autism Spectrum Disorder, Neurodevelopmental Disorders
Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders
Neurodevelopmental disorders such as attention deficit disorder with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia…
- Trial name
- MARIANNE (NCT05681923)
- Testing
- Questionnaires, Biospecimen collection, Neurodevelopmental assessment visit
- Where
- France
- Volunteers
- 7,320 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Nonorganic Insomnia, Neurodevelopmental Disorders
Better Nights, Better Days for Children With Neurodevelopment Disorders
More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems, whereas less than 25% of typically developing children experience sleep problems.
- Conditions
- Nonorganic Insomnia, Neurodevelopmental Disorders, Primary Insomnia
- Trial name
- BNBD-NDD (NCT02694003)
- Testing
- BNBD-NDD Intervention
- Where
- Canada
- Volunteers
- 218 people
- Sponsor
- IWK Health Centre
CMV, Prenatal Diagnosis
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects almost all humans at some point in their lives (Ross, 2004).
- Conditions
- CMV, Prenatal Diagnosis, Ultrasound, MRI
- Trial name
- NCT00872703
- Where
- Israel
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS)
Development of Education Materials for Prevention of FAS in Russia
This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder, Alcohol Use Complicating Pregnancy, Unspecified Trimester
- Trial name
- NCT01971398
- Testing
- Positive FASD education brochure, Negative FASD education brochure, Active comparator (a general women's health brochure)
- Where
- 3 sites in United States, Russia
- Volunteers
- 422 people
- Sponsor
- University of Oklahoma
Fetal Alcohol Spectrum Disorder
Parenting Training for Children With FASD
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada.
- Trial name
- SF-FASD (NCT02210455)
- Testing
- Strongest Families FASD intervention, Psychoeducation
- Where
- Canada
- Volunteers
- 119 people
- Sponsor
- IWK Health Centre
Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders
Preventing FAS/ARND in Russian Children
The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children.
- Conditions
- Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
- Trial name
- NCT01961050
- Testing
- Dual-Focused Brief Physician Intervention (DFBPI), Services as usual
- Where
- 2 sites in Russia
- Volunteers
- 767 people
- Sponsor
- University of Oklahoma
Fetal Growth Retardation, Stillbirth and Fetal Death
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments…
- Conditions
- Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm
- Trial name
- PROTECTMe (NCT05651347)
- Testing
- Melatonin 10 MG
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Monash University
Diabetes, Endocrine System Diseases
Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial
The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to…
- Conditions
- Diabetes, Endocrine System Diseases, Gastro-Intestinal Disorder, Neuro-Degenerative Disease
- Trial name
- TNT (NCT03342495)
- Testing
- Patient Navigator, Usual Care
- Where
- 3 sites in Canada
- Volunteers
- 337 people
- Sponsor
- University of Calgary
Encephalopathy, Birth Defect
Clinical Utility of Pediatric Whole Exome Sequencing
The investigator aims to examine the clinical utility of WES, including assessment of a variety of clinical outcomes in undiagnosed pediatric cases.
- Conditions
- Encephalopathy, Birth Defect, Intellectual Disability, Multiple Congenital Anomaly
- Trial name
- NCT03525431
- Testing
- Whole Exome Sequencing
- Where
- 4 sites in United States
- Volunteers
- 529 people
- Sponsor
- University of California, San Francisco
Neurodevelopmental Disorders, Child Behavior
Neurodevelopmental Outcome After Prenatal Anesthesia
In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three.
- Trial name
- NCT06052878
- Testing
- Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF), Parental questionnaire about their child's cognitive functioning in their daily life and medical history.
- Where
- France
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Fetal Alcohol Syndrome, Attention Deficit Hyperactivity Disorder (ADHD)
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
- Trial name
- B4Z-US-050 (NCT00418262)
- Testing
- Atomoxetine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Oklahoma
Biomarkers, Neurodevelopmental Disorders
Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults
Inflammation during pregnancy represents an important risk factor for the development of neuropsychiatric disorders in the offspring.
- Conditions
- Biomarkers, Neurodevelopmental Disorders, Inflammation, Brain
- Trial name
- MATERNALLY (NCT06852703)
- Testing
- Infection during pregnancy
- Where
- Italy
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Istituto Clinico Humanitas
Cannabis Use Disorder, PREG1
The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity
Cannabis is the most commonly used drug by women during pregnancy with an estimated prevalence of use in Colorado of 5.7%. THC and its metabolites freely cross the placenta and blood-brain barrier to bind with cannabinoid…
- Conditions
- Cannabis Use Disorder, PREG1, Drug Use, Fetal Exposure During Pregnancy
- Trial name
- NCT03718520
- Testing
- no intervention, this is a purely observational study
- Where
- 2 sites in United States
- Volunteers
- 168 people
- Sponsor
- University of Colorado, Denver
Asparagine Synthetase Deficiency, Genetic Diseases, Inborn
Study on the Mechanism of Neurodevelopment Dysplasia of Fetal Brain Caused by ASNS Gene Mutation
The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.
- Trial name
- NCT03587155
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The First Hospital of Jilin University
Bilirubin Encephalopathy
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
- Trial name
- NCT04584983
- Testing
- usual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The University of Texas Health Science Center, Houston
Gonad Regulating Hormone Adverse Reaction, Analgesic Adverse Reaction
Neurobehavioral Development in Toddlers and Preschoolers in Relation to Prenatal Exposure of Mild Analgesics (NeuroToP - a COPANA Follow up)
Fundamental aspects of both neurological and reproductive function are established in fetal life, and there is a present increased awareness of the potential effects of fetal exposures on neurodevelopmental and reproductive…
- Conditions
- Gonad Regulating Hormone Adverse Reaction, Analgesic Adverse Reaction, Developmental Disability, Adhd
- Trial name
- NeuroToP (NCT07316387)
- Where
- Denmark
- Volunteers
- 685 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder
- Trial name
- NCT01149538
- Testing
- Choline bitartrate
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Minnesota