Clinical trials: Infant Neurodevelopment, active
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
Infant, Newborn, Diseases, Infant Development
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32…
- Trial name
- NCT05945017
- Testing
- Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
- Where
- Spain
- Volunteers
- 233 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
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
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
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
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 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
Preterm Birth, Neurodevelopmental Disorders
Guangzhou Preterm and Term Birth Cohort Study
The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a prospective observational study of how early-life nutrition, environmental exposures, and family factors relate to the health and development of preterm and term infants and…
- Conditions
- Preterm Birth, Neurodevelopmental Disorders, Overweight, Obesity
- Trial name
- GPTBC (NCT07756177)
- Testing
- No Intervention: Observational Cohort
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
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
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
MLD, Krabbe Disease
Longitudinal Study of Neurodegenerative Disorders
The purpose of this study is to understand the course of rare genetic disorders that affect the brain. This data is being analyzed to gain a better understanding of the progression of the rare neurodegenerative disorders and the…
- Conditions
- MLD, Krabbe Disease, ALD, MPS I
- Trial name
- NCT03333200
- Testing
- Palliative Care, Hematopoetic Stem Cell Transplantation
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- University of Pittsburgh
Infant, Premature, Diseases
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants).
- Trial name
- M-MILK RCT (NCT07216664)
- Testing
- Multisensory early oral administration of human milk
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Loyola University
Pediatrics, Neurological Abnormality
Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE)
The American Academy of Pediatrics defines infants at risk as those with preterm birth, special health care needs, family risk factors, and those at risk of early death.
- Conditions
- Pediatrics, Neurological Abnormality, Neurodevelopment Outcome
- Trial name
- BRIEF-HINE (NCT07182474)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Kahramanmaras Sutcu Imam 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
Infant Development
Assessment of Motor Development With a Wearable in Rural and Low-income Settings
The MaMa study aims to assess feasibility and validity of an infant wearable in a rural settings. Altogether N~100 infants will be recruited and measured multiple times at homes from age 6 months to age 18 months.
- Trial name
- MaMa (NCT05782673)
- Testing
- wearable MAIJU for motor assessment
- Where
- 4 sites in Finland, Malawi
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital