Clinical trials: Neurodevelopment, open to volunteers
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Serious Suicide Attempt
Associated Psychiatric Disorders in Children Hospitalized for a Serious Suicide Attempt
Several studies agree on the increase in suicide attempts in children over the past 15 years. This trend has been aggravated by the COVID 19 pandemic.
- Trial name
- SuiciDev (NCT05450354)
- Testing
- Questionnaires, Questionnaire
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
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
Preterm Birth, Developmental Dyslexia
Reading-FREE Markers for Early Detection of Developmental Dyslexia
This study aims to identify early signs of developmental dyslexia (DD) and other reading difficulties in children born preterm, using behavioral, cognitive, and brain imaging data collected before reading problems typically…
- Trial name
- FREE-DD (NCT07072104)
- Testing
- Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 2, MRI - Grade 2, Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 3
- Where
- Italy
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Università Vita-Salute San Raffaele
Child Development, Motor Skills
Motor-Focused Exercise and Brain Development in Preschool Children
This study will test whether a structured motor-focused exercise program can improve both brain function and gross motor skills in preschool children.
- Conditions
- Child Development, Motor Skills, Neurodevelopment, Brain Function
- Trial name
- MoBraD (NCT07307742)
- Testing
- Motor-Focused Physical Education, Ordinary Physical Education
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Hunan Normal University
Oral Feeding Outcomes, Neurodevelopment Outcome
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments.
- Trial name
- H-HOPE (NCT07372898)
- Testing
- H-HOPE
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Early Childhood Development, Infant Development
Understanding Early Development of Infants and Toddlers
The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive…
- Conditions
- Early Childhood Development, Infant Development, Child Development
- Trial name
- NCT07418528
- Testing
- Psychological developmental assessment
- Where
- Poland
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Bartosz M. Radtke
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
Neurofibromatosis Type 1
Gait in Young Children With NF1
The objective of this study is to develop office-based tools to quantify gait in young children with NF1 that reflect overall gross motor impairment and predict future gross motor difficulties.
- Trial name
- NCT07564622
- Volunteers
- 56 people
- Sponsor
- NYU Langone Health
Hypoxic-Ischemic Encephalopathy
School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy
Neonatal HIE increases the risk for cognitive impairments in childhood. Neonatal MRI brain scans are a strong predictor for outcome, however a normal scan has only a 35% sensitivity and 85% specificity for a normal outcome.
- Trial name
- SOPHIE (NCT07770035)
- Where
- Ireland
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- University College Cork
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
Premature Birth
Effect of the IBAIP in Preterm Infants Neurodevelopment
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as…
- Trial name
- IBAIP (NCT04685356)
- Testing
- IBAIP : Infant Behaviour Assessment and Intervention Program, Standard Support, Ages and Stages Questionnaire (ASQ)
- Where
- 9 sites in France
- Volunteers
- 240 people
- Sponsor
- University Hospital, Brest
Complex Congenital Heart Disease
Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children.
- Trial name
- Et APRéS Ca (NCT06884046)
- Testing
- Personalized support project
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Bordeaux
Neurodevelopment, Child Growth
Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa
The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe).
- Trial name
- BONDS (NCT07430826)
- Testing
- Friendship Bench, Infant and Young Child Feeding (IYCF) Curriculum, Play-Based Curriculum
- Volunteers
- 1,260 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection
Detection of Specific Metabolic Signatures by Nuclear Magnetic Resonance or Metabolomic NMR in Correlation With Markers of Inflammation or Immune Activation and the Risk of Developing Neurocognitive Disorders - Longitudinal Retrospective Study Nested in the ANRS12225 PEDIACAM III Cohort
The ANRS12225 PEDIACAM III cohort involves a cohort of young adolescents living with HIV placed early (median: 4 months) on antiretroviral therapy (ART) and living without HIV monitored in Cameroon.
- Trial name
- ANRS0213sMIND (NCT07770568)
- Volunteers
- 128 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Infant Neurodevelopment, Nutrition
Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
This prospective cohort study examines the relationship between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment.
- Conditions
- Infant Neurodevelopment, Nutrition, Methylation, Birth Outcomes
- Trial name
- NCT07568561
- Where
- 2 sites in Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Far Eastern Memorial Hospital
Infant Development, Language Development
The Impact of Music Medicine on Preterm Brain Development and Behavior
The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork…
- Conditions
- Infant Development, Language Development, Prematurity, Stress
- Trial name
- NCT06536296
- Testing
- Music, Music and parent voice, Standard Care
- Where
- 2 sites in United States
- Volunteers
- 243 people
- Sponsor
- Brigham and Women's Hospital