Clinical trials: Neurodevelopment, active
Congenital Heart Disease, Neurodevelopmental Disorders
Predictive Value of Neurovascular Coupling in Infants With COngenital Heart Disease
Infants with congenital heart disease (CHD) are at increased risk for delayed neurodevelopment. Multiple etiological explanations have been proposed, as there seems to be a multifactorial interplay of both prenatal and…
- Conditions
- Congenital Heart Disease, Neurodevelopmental Disorders, Electroencephalography, Near-Infrared Spectroscopy
- Trial name
- NICO (NCT06190210)
- Testing
- electroencephalography, Near-Infrared Spectroscopy, neuronal cell-free DNA
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Cerebral Palsy Infantile, Pre-Term
Motor-voice Assessment in Infants (MAMI)
The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants..
- Conditions
- Cerebral Palsy Infantile, Pre-Term, Motor Delay, Neurodevelopmental Disorders
- Trial name
- MAMI (NCT06807203)
- Testing
- Behavioral observation
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Ohio State University
Pregnant Women, Labor Pain
Neuraxial Labor Analgesia and Offspring Neurodevelopment
How perinatal factors affect the long-term development of children has always been an issue of much concern. This study is designed to explore the potential impact of maternal neuraxial labor analgesia exposure on offspring…
- Conditions
- Pregnant Women, Labor Pain, Analgesia, Epidural, Infants
- Trial name
- NCT04964206
- Testing
- Neuraxial labor analgesia, No neuraxial labor analgesia
- Where
- 2 sites in China
- Volunteers
- 4,645 people
- Sponsor
- Dong-Xin Wang
Neurological and Mental Health Conditions, Genetic Susceptibility
Mapping Antenatal Maternal Stress
This study recruits women from early-mid pregnancy and later follows their children after birth, tracking both the mother and child until the child reaches at least 4 years of age.
- Conditions
- Neurological and Mental Health Conditions, Genetic Susceptibility, Socioeconomic Factors, Psychology, Social
- Trial name
- MAMS (NCT07432217)
- Where
- Singapore
- Volunteers
- 1,419 people, healthy volunteers welcome
- Sponsor
- Institute for Human Development and Potential (IHDP), Singapore
Prematurity, Iron-deficiency
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency…
- Conditions
- Prematurity, Iron-deficiency, Iron Deficiency Anemia, Iron Malabsorption
- Trial name
- DIVI (NCT05340465)
- Testing
- Darbepoetin Alfa, Low Molecular Weight Iron Dextran, Ferumoxytol injection
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Washington
Children With Typical Neurodevelopment
PLAY UP: An Intervention Program Through Active Play and Environmental Affordances
The goal of this cluster-randomized trial is to investigate how a co-created, affordance-based approach - developed in collaboration with children - and combined with educator training, can support preschool children's engagement…
- Trial name
- PLAY UP (NCT07355179)
- Testing
- PLAY UP
- Where
- Portugal
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Évora
Autism, Neurodevelopment
Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals
Many people with autism and other developmental conditions have difficulty speaking or do not use speech and need other ways to communicate.
- Trial name
- AAC (NCT07581483)
- Testing
- Automated AAC Assessment and Low-Tech AAC Implementation Support, Standard AAC Support
- Where
- 2 sites in United States, Kenya
- Volunteers
- 500 people
- Sponsor
- Indiana University
Preterm Birth
Environmental Enrichment Intervention and Brain Development in Preterm Infants
This study aims to evaluate the effects of a structured environmental enrichment (EE)-based early developmental intervention on brain, motor, and cognitive outcomes in preterm infants.
- Trial name
- PRE-ENV (NCT07343505)
- Testing
- Standard Developmental Care, Environmental Enrichment-Based Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people
- Sponsor
- Eskisehir Osmangazi University
Neurological and Mental Health Conditions, Genetic Susceptibility
Mapping Antenatal Maternal Stress - Child Outcomes
This study is a sub-study of Mapping Antenatal Maternal Stress (MAMS). Women previously enrolled in MAMS, their children and their partners/spouses were recruited for a set of more comprehensive assessments to characterise early…
- Conditions
- Neurological and Mental Health Conditions, Genetic Susceptibility, Socioeconomic Factors, Psychology, Social
- Trial name
- MAMS-CO (NCT07432243)
- Where
- Singapore
- Volunteers
- 587 people, healthy volunteers welcome
- Sponsor
- Institute for Human Development and Potential (IHDP), Singapore
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders.
- Trial name
- NCT04395196
- Testing
- Choline bitartrate
- Where
- South Africa
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Wayne State University
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Klinefelter Syndrome, Trisomy X
The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy
This study is designed to research the natural history of neurodevelopment, health and early hormonal function in infants with XXY/Klinefelter syndrome, XYY, XXX and other sex chromosome variations in an effort to identify early…
- Conditions
- Klinefelter Syndrome, Trisomy X, XYY Syndrome, XXXY and XXXXY Syndrome
- Trial name
- NCT03396562
- Testing
- Assessments of Development and Growth
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Colorado, Denver
Intrauterine Hyperglycemia, Pregnancy Outcomes
The Born in Guangzhou Cohort Study (BIGCS)
The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China.
- Conditions
- Intrauterine Hyperglycemia, Pregnancy Outcomes, Neurodevelopment, Immune Development
- Trial name
- BIGCS (NCT02526901)
- Testing
- No intervention
- Where
- China
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- Guangzhou Women and Children's Medical Center
Thyroid Function, Preterm
Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug/kg/d, initiated in the second week of life, improves physical growth and neurodevelopmental…
- Conditions
- Thyroid Function, Preterm, SGA and Growth, Neurodevelopment Outcome
- Trial name
- NCT07625722
- Testing
- Levothyroxine Sodium (LT4) Tablets
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Shandong Provincial Hospital
Gestational Diabetes Mellitus, Pregnancy Outcome
GDM and Its Consequences in Mothers and Offsprings
Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term…
- Conditions
- Gestational Diabetes Mellitus, Pregnancy Outcome, Neurodevelopment, Immune Development
- Trial name
- GDMCMO (NCT04529889)
- Where
- China
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- Guangzhou Women and Children's Medical Center
Cerebral Visual Impairment
Neurodevelopmental Outcomes in Cerebral Visual Impairment
Cerebral visual impairment (CVI) is one of the leading causes of pediatric visual impairment and negatively impacts the development of motor, language, and cognitive skills.
- Trial name
- CVI-ND (NCT07212010)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Pregnancy Related, Vitamin B 12 Deficiency
Vitamin B12 Supplementation During Pregnancy on Cognitive Development
Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption.
- Conditions
- Pregnancy Related, Vitamin B 12 Deficiency, Anemia
- Trial name
- VitaPreg (NCT03071666)
- Testing
- cobalamin
- Where
- Nepal
- Volunteers
- 800 people
- Sponsor
- Centre For International Health
Pregnancy, Child Development
Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation
The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether…
- Trial name
- NAPS (NCT02647723)
- Testing
- DHA, Sugar pill
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Parent-Child Relations
Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child
The objective of the study is to assess the psychic profile of parents of children born prematurely
- Trial name
- PoPPY (NCT04827225)
- Testing
- questionnaires
- Where
- 2 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Neurodevelopment Outcome, Linear Growth
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
MEDHA is a randomized controlled trial among 10-18 year old girls to examine the use-case of the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS)…
- Conditions
- Neurodevelopment Outcome, Linear Growth, Micronutrient Status, Bone Mineral Density
- Trial name
- MEDHA (NCT07695883)
- Testing
- Iron (60 mg)- folic acid (400 ug) [IFA], Multiple micronutrient supplement [MMS], Multiple micronutrient supplement Plus [MMS+]
- Where
- Bangladesh
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health