Clinical trials: Neurodevelopment, open to volunteers
Excessive Crying, Prolonged Pain
Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study
NEOTHERM is a multicenter, prospective, observational pilot study examining whether infrared thermal imaging (ITI) can contribute to the assessment of prolonged pain in infants with excessive crying.
- Trial name
- NEOTHERM (NCT07693179)
- Where
- 3 sites in France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier de Saint-Denis
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
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
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
Sleep
Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
To examine the effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment, the researchers will recruit 80 pregnant women with sleep disturbances.
- Trial name
- NCT06514833
- Testing
- lifestyle recommendations to nap regularly, No recommendations to nap regularly
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
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
Premature Birth, Neurodevelopmental Disorders
Probiotics Supplementation for Neurodevelopment in Preterm Infants
The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure.
- Conditions
- Premature Birth, Neurodevelopmental Disorders, Dysbiosis
- Trial name
- NCT07617181
- Testing
- Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
Infant Sleep Problems, Circadian Rhythm
Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
- Conditions
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- Trial name
- NCT07533578
- Testing
- Chronobiologically Timed Feeding of Expressed Breast Milk, Usual Feeding Practice (Untimed Expressed Breast Milk)
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Luzerner Kantonsspital
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD
The primary goals of this phase 2 clinical trial are to determine the feasibility, safety, and tolerability of oral Fecal Microbiota Transplantation (FMT) in adolescents (aged 13-17) with Attention-Deficit/Hyperactivity Disorder…
- Conditions
- ADHD, ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
- Trial name
- FMT-ADHD-2026 (NCT07756255)
- Testing
- Fecal Microbiota Transplant (FMT), Nitazoxanide 500mg BID, Vancomycin 250mg BID
- Where
- Canada
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Hereditary Transmission, Immune Development
Maternal Grandmothers in the Born in Guangzhou Cohort Study
The MGBIG is a study exploring cross-generational effects in 5000 women and their children and grandchildren located in Guangzhou, China.
- Conditions
- Hereditary Transmission, Immune Development, Childhood Obesity, Host and Microbiome
- Trial name
- MGBIG (NCT03633162)
- Where
- China
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Guangzhou Women and Children's Medical Center
Neurodevelopmental Disorders
NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory…
- Trial name
- NCT06087744
- Testing
- NeuroN-QI, SSC alone
- Where
- 2 sites in Canada
- Volunteers
- 124 people
- Sponsor
- St. Justine's Hospital
Premature Birth, Antibiotics
NICU Antibiotics and Outcomes (NANO) Follow-up Study
The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of…
- Conditions
- Premature Birth, Antibiotics, Neurodevelopment
- Trial name
- NANO-FU (NCT05977400)
- Testing
- Ampicillin, Gentamicin
- Where
- 15 sites in United States, Canada
- Volunteers
- 802 people
- Sponsor
- Sharp HealthCare
Congenital Heart Disease, Child Development
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
The proposed study aims to determine the feasibility of the procedures for a future full randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga intervention in reducing attention deficits in…
- Conditions
- Congenital Heart Disease, Child Development, Neurodevelopmental Disorders, Parents
- Trial name
- NCT05997680
- Testing
- Parent-child yoga
- Where
- 2 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Anne Gallagher
Visual Impairment, Cerebral Visual Impairment
VIPPSTAR-G1 Digital Early Intervention for Visual Impairment
Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental…
- Conditions
- Visual Impairment, Cerebral Visual Impairment, Neurodevelopmental Disorders, Prematurity
- Trial name
- VIPPSTAR-G1 (NCT07717671)
- Testing
- VIPPSTAR Digital Early Intervention, Standard Clinical Care
- Where
- 5 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- Università degli Studi di Brescia
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
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
Neurodevelpmental Delays, Neurodevelopment
Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV
The goal of this study is to learn about how to best carry out neurodevelopmental screening methods (tests to see if a young child can use support with brain development) in routine clinic visits in Botswana and Kenya among…
- Conditions
- Neurodevelpmental Delays, Neurodevelopment, Neurodevelopment Outcome
- Trial name
- IMPLEMENT (NCT07457411)
- Testing
- Neurodevelopmental screening
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
Congenital Heart Diseases, Children
Physical Activity and Cognitive Development in Children
1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and…
- Trial name
- NCT02542683
- Testing
- structured physical activity program
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Columbia University
Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development
TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index
This is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial in mother-infant dyads. The study aims to evaluate the safety, tolerability, and biological effects of maternal oral tauroursodeoxycholic acid…
- Trial name
- MILK-HI-TUDCA (NCT07517276)
- Testing
- tauroursodeoxycholic acid (TUDCA)
- Volunteers
- 80 people
- Sponsor
- Peking University First Hospital