Clinical trials: Fetal Neurodevelopmental Disorder
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Congenital Heart Disease, Periventricular Leucomalacia
Randomized Trial of Maternal Progesterone Therapy
Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a…
- Conditions
- Congenital Heart Disease, Periventricular Leucomalacia, Brain Development, Cardiac Surgery
- Trial name
- NCT02133573
- Testing
- Progesterone, Vaginal lubricant
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Children's Hospital of Philadelphia
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, 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
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol-related Neurodevelopmental Disorder
- Trial name
- NCT01911299
- Testing
- Choline
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- San Diego State University
Persistent Pulmonary Hypertension of the Newborn
NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn
Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns.
- Trial name
- NEUROPHON (NCT04841070)
- Testing
- Ages & Stages Questionnaires®, Third Edition (ASQ3)
- Where
- France
- Volunteers
- 55 people
- Sponsor
- University Hospital, Toulouse
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
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
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
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
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
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
Premature Birth, Neonatal Hypoglycemia
Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies
The goal of this observational study was to compare two doses of dexamethasone given to pregnant women at risk of preterm birth. Dexamethasone is a medicine used before birth to help a baby's lungs mature.
- Conditions
- Premature Birth, Neonatal Hypoglycemia, Maternal Infection During Pregnancy, Neurodevelopmental Disorder of Foetus
- Trial name
- NCT07765329
- Testing
- Dexamethasone 12 mg Every 12 Hours, Dexamethasone 6 mg Every 12 Hours
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- Stella Maris Women and Children Hospital
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
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 and Neonatal Alloimmune Thrombocytopenia, Long Term Adverse Effects
Neurodevelopmental Outcome After Fetal Neonatal AlloImmune Thrombocytopenia
Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a disease caused by allo-immunisation during pregnancy. If left untreated, FNAIT can lead to severe fetal intracranial haemorrhage.
- Conditions
- Fetal and Neonatal Alloimmune Thrombocytopenia, Long Term Adverse Effects, Neurodevelopmental Abnormality, Intravenous Immunoglobulin Adverse Reaction
- Trial name
- NOFNAIT (NCT04529382)
- Testing
- Cognitive testing (Bayley III, WPPSI III and WISC V)
- Where
- Netherlands
- Volunteers
- 78 people
- Sponsor
- Leiden University Medical Center
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
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
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
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