Clinical trials: Fetal Neurodevelopmental Disorder
Cocaine, Substance Abuse
The Maternal Lifestyle Study (MLS)
This is a longitudinal, multi-site observational study of the long-term effects of a mother's use of cocaine and/or opiates during pregnancy on her infant.
- Conditions
- Cocaine, Substance Abuse, Infant, Newborn, Pregnancy
- Trial name
- MLS (NCT00059540)
- Where
- 5 sites in United States
- Volunteers
- 11,811 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Fetal Alcohol Spectrum Disorders
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
The purpose of this study is to help scientists understand why some people who were exposed to alcohol in the womb have special facial features but other people do not.
- Trial name
- DiGFASD (NCT04072809)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Indiana University
Fetal Growth Retardation, Fetal Neurodevelopmental Disorder
Fetal Magnetic Resonance Imaging: Z-score Reference Ranges for a Large Patient Population in Normal Neuroimaging Measurement
This study aims to establish the z score reference ranges of fetal head circumference and other measurement of fetal measurements including biparietal diameter, fronto-occipital diameter, length of the corpus callosum, lateral…
- Trial name
- FMZSCORE (NCT07004283)
- Where
- China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Guangzhou Women and Children's Medical Center
Metabolic Diseases, Neurological and Mental Health Conditions
Growing Up in Singapore Towards Healthy Outcomes
This study aims to examine the role of genetic and epigenetic factors, maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of…
- Conditions
- Metabolic Diseases, Neurological and Mental Health Conditions, Genetic Predisposition, Skin Condition
- Trial name
- GUSTO (NCT01174875)
- Where
- Singapore
- Volunteers
- 1,247 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies.
- Conditions
- Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Neurodevelopmental Disorder, EEG; Spikes, Centrotemporal, Epilepsy of Childhood
- Trial name
- NCT01942525
- Testing
- aEEG
- Where
- Austria
- Volunteers
- 156 people
- Sponsor
- Medical University of Vienna
Pregnancy Related, Neurodevelopmental Disorders
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
A randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (>165 μg/d from food alone) on cognitive development of children at…
- Conditions
- Pregnancy Related, Neurodevelopmental Disorders, Nutrition Disorder, Fetal
- Trial name
- PoppiE (NCT04586348)
- Testing
- Low Iodine Supplement, Standard Iodine Supplement
- Where
- Australia
- Volunteers
- 794 people, healthy volunteers welcome
- Sponsor
- South Australian Health and Medical Research Institute
Child Development Disorders, Pregnancy
The Effect of Thyroid Hormone Levels in Pregnant Women on the Intelligence Quotient (IQ) of Their Children
This study is designed to test the hypothesis that the level of the thyroid hormone thyroxine (specifically, free thyroxine, FT4) circulating in the blood of pregnant women is the key thyroid-related factor to influence early…
- Conditions
- Child Development Disorders, Pregnancy, Subclinical Hypothyroidism
- Trial name
- NCT00147433
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Fetal Alcohol Spectrum Disorders
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline.
- Trial name
- CHOLINE4 (NCT05108974)
- Testing
- Choline Bitartrate
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Jeff Wozniak
Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder
Monitoring and Evaluation of a Cognitive Behavioral Therapy Program Focused on Attention and Emotion Regulation for Children With Fetal Alcohol Spectrum Disorder
This is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment.
- Conditions
- Fetal Alcohol Spectrum Disorders, Hyperactivity Disorder, Attention Deficit
- Trial name
- SEPAGE (NCT05273918)
- Testing
- cognitivo-comportmental therapy, body mediation
- Where
- 3 sites in France, Reunion
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Fetal Alcohol Spectrum Disorders
FASST - Fetal Alcohol Spectrum Stimulant Trial
This study is a double-blind, placebo controlled, series of N-of-1 trials of individualised stimulant dose on ADHD symptomatology in children with FASD.
- Trial name
- FASST (NCT04968522)
- Testing
- Methylphenidate Hydrochloride, Methylphenidate Hydrochloride 18 MG, Dexamphetamine sulfate
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Monash Medical Centre
Executive Function Deficits (EFD), Developmental Coordination Disorder
Let's CO-OPerate! Together we Are Stronger
The goal of this replicated single case experimental study using a randomized multiple baseline design across participants and goals is to enable children/adolescents (aged 8-16 years) with developmental coordination disorders…
- Conditions
- Executive Function Deficits (EFD), Developmental Coordination Disorder, Acquired Brain Injury (Including Stroke), Brain Injury, Fetus and Neonate
- Trial name
- NCT07085403
- Testing
- Cognitive Orientation to daily Occupational Performance (CO-OP) is a cognitive problem-solving approach
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Hopitaux de Saint-Maurice
Severe Intra-uterine Growth Restriction, Preterm Birth
Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
- Conditions
- Severe Intra-uterine Growth Restriction, Preterm Birth, Neurodevelopmental Disorders, Placental Insufficiency
- Trial name
- NCT05381272
- Volunteers
- 20 people
- Sponsor
- Central Hospital, Nancy, France
General Anaesthesia During Pregnancy
Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia
Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy.
- Trial name
- PAE-IQ (NCT06633406)
- Testing
- Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale, Social Responsiveness Scale
- Where
- 3 sites in Belgium
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD)
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
- Conditions
- Fetal Alcohol Syndrome, Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)
- Trial name
- B4Z-MC-X017 (NCT00417794)
- Testing
- Strattera
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Oklahoma
Fetal Alcohol Syndrome, Alcohol-related Neurodevelopmental Disorder
Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)
Children will receive comprehensive evaluations through the Children's Research Triangle (CRT) clinical program. The assessment for the child will be in accordance with the protocol developed by Astley and Clarren as performed by…
- Trial name
- NCT00164346
- Testing
- neurocognitive habilitation
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Congenital Heart Disease in Children, Hypoxia
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart…
- Conditions
- Congenital Heart Disease in Children, Hypoxia, Neurodevelopmental Disorders, Complex Congenital Heart Disease
- Trial name
- NCT05767385
- Testing
- Single Arm, Neonatal Neurobehavioral Scale
- Where
- 5 sites in United States
- Volunteers
- 104 people
- Sponsor
- University of Utah
Premature Birth, Premature Infant
Growing Little PEAPODS Study
The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth…
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction
- Trial name
- NCT06226051
- Testing
- PEAPOD Infant Body Composition measuring device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Wisconsin, Madison
Epilepsy, Neurodevelopmental Disorders
The Biomarkers of Neurological Disease in Utero Study
Anti-epileptic drugs (AEDs) are potent teratogens associated with a spectrum of physical and neurodevelopmental anomalies to the exposed fetus.
- Conditions
- Epilepsy, Neurodevelopmental Disorders, Fetal Disease, Teratogenesis
- Trial name
- BONDING (NCT04043572)
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nottingham University Hospitals NHS Trust
Microcephaly, Mental Retardation
Neurodevelopment Outcome of Newborns Exposed to Zika Virus (ZIKV) in Utero
This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome.
- Trial name
- ZENI (NCT02943304)
- Testing
- Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
- Where
- Colombia
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- Universidad Industrial de Santander