Neurodevelopment

13

Review clinical trials related to Neurodevelopment. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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. Augmentative and alternative communication (AAC) includes tools such as picture boards, communication books, and gestures that support communication. In low-resource settings and underserved rural areas in the United States, high-tech AAC devices are often too expensive or difficult to access, and trained specialists are limited. Low-tech AAC options are more affordable but are often not used successfully because tools may not match the individual's abilities or daily environment, caregivers and providers may lack training, and stigma or low awareness may discourage use. These challenges can lead to AAC abandonment and social isolation. Rural Virginia and western Kenya face similar barriers, including limited AAC expertise, inconsistent assessment, and insufficient training for families, educators, and community providers. This project uses a shared learning approach that combines western Kenya's experience implementing low-tech AAC in new settings with rural Virginia's expertise in individualized assessment, training, and scalable service delivery. The goal is to better match individuals to appropriate low-tech AAC systems and support communication partners to use them effectively.

Participants needed: 500
Trial details
Age: 3-14Biological sex: AllType: InterventionalSponsor: Indiana UniversityUpdated: May 12, 2026Locations: 2
Eligibility criteria

Communication partners (e.g., caregivers, parents, teachers, community health wo... [+5]

Communication partners younger than 18 years of age [+4]

Status: Not yet recruiting

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. In early life, infants produce very little of the hormone melatonin, which plays a key role in regulating sleep and circadian rhythms. Breast milk naturally contains melatonin, and its levels vary across the day, with higher concentrations at night. This variation may provide important biological signals that help infants develop healthy sleep-wake patterns. However, expressed breast milk is often fed without considering the time it was expressed. This may disrupt the transfer of circadian signals from mother to infant. The aim of this randomised controlled trial is to determine whether feeding expressed breast milk according to the time of expression (e.g. giving night-time milk at night) improves sleep consolidation and circadian development compared with usual feeding practices. A total of 200 preterm infants born between 32+0 and 36+6 weeks' gestation who are receiving expressed breast milk will be enrolled and randomly assigned to one of two groups: Intervention group: preterm infants receive expressed breast milk matched to the time of day it was expressed (day, evening or night) Control group: preterm infants receive expressed breast milk without regard to timing (usual practice) The main outcome is sleep consolidation at 6 months of age, measured objectively using actigraphy (a small wearable device that records sleep and activity). Additional outcomes include sleep patterns over time, circadian development, melatonin exposure, gut microbiota composition, and clinical outcomes such as infections and neurodevelopment. The intervention does not involve any medication and uses the infant's usual nutrition. Risks are minimal and mainly relate to the additional effort required for milk labelling and timing. This study will provide evidence on whether a simple, low-risk change in feeding practice can support infant sleep and early-life circadian development, with potential benefits for child health and family well-being.

Participants needed: 200
Trial details
Age: 0-1Biological sex: AllType: InterventionalSponsor: Luzerner KantonsspitalUpdated: Apr 16, 2026Locations: 1
Eligibility criteria

Preterm infants born between 32+0 and 36+6 weeks' gestation [+4]

Prenatal exposure to illicit drugs (e.g. cannabis, cocaine, heroin, opiates) or... [+2]

Status: Not yet recruiting

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 children age 16-24 months old. The main questions it aims to answer are: 1. when used in routine clinic visits by healthcare workers, how many children are able to get screened; 2. are the screening tools appropriate and how can they best be used; 3. how much time and money does it take to use the screening methods? The investigators will compare two screening methods chosen by healthcare workers at the beginning of the study. Children will undergo a brief test of their brain development to see if they need further evaluation and support. Caregivers will be asked to complete a short survey to see what they thought of the screening test. Healthcare workers will complete brief surveys and interviews to see what they thought of carrying out the screening tests and how use of the screening tests can be improved in their clinics.

Participants needed: 5,000
Trial details
Age: 16+Biological sex: AllType: InterventionalSponsor: University of WashingtonUpdated: Mar 9, 2026
Eligibility criteria

Healthcare workers (HCW): age 18 years or older [+5]

None

Status: Not yet recruiting

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). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. The main objectives of this study are to: * Determine whether the adapted package of interventions improves neurodevelopment among children with and without in utero HIV exposure * Identify why the intervention does or does not impact children's neurodevelopment. Researchers will compare children who receive the intervention package and those who do not to see if the interventions improve child neurodevelopment and growth. Researchers will also compare children with and without HIV exposure to see if there are improvements in neurodevelopment and growth for children who were exposed to HIV. All participants will attend regular prenatal and postnatal care appointments. Participants who are randomized to receive the package of interventions will attend regularly scheduled visits where they will discuss problem-solving strategies, receive information on healthy foods for children, and learn about how to play with their children. Mothers receiving the intervention package will also have the opportunity to meet with other mothers and babies in small groups where their children can play together.

Participants needed: 1,260
Trial details
Age: 15+Biological sex: FemaleType: InterventionalSponsor: University of WashingtonUpdated: Mar 3, 2026
Eligibility criteria

Pregnant woman attending participating clinics [+4]

Incarcerated individuals [+3]

Status: Not yet recruiting

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. About 110 children aged 4 to 6 years will be recruited from kindergartens in Changsha, China. Classes will be randomly assigned to receive either (1) motor-focused physical education three times per week for 16 weeks, or (2) ordinary physical education of the same frequency and duration. The motor-focused program includes playful, game-based activities designed to strengthen locomotor skills (such as running and hopping) and object-control skills (such as throwing and catching). The main outcome will be changes in children's gross motor skills, measured with a standardized motor test (TGMD-3). Brain activity will also be assessed using portable electroencephalography (EEG) during rest and simple tasks related to attention and memory. Parents and teachers will complete short questionnaires about children's behavior and executive function. The results of this study may provide new insights into how physical education influences both movement skills and brain development in early childhood.

Participants needed: 110
Trial details
Age: 4-6Biological sex: AllType: InterventionalSponsor: Hunan Normal UniversityUpdated: Dec 29, 2025
Eligibility criteria

Children aged 4 to 6 years enrolled in participating kindergartens in Changsha,... [+2]

Diagnosed neurological, developmental, or musculoskeletal disorders that may int... [+2]

Status: Recruiting

Investigating the Impacts of Early Life Experience on the Brain & Behaviour

The aim of this study is to learn more about how early life experience influences the brain, behaviour, and the immune system later in life. This will help improve understanding of why certain early life experiences (e.g., adoption, stress and parental separation) can cause difficulties for some people when they are adults. The long-term goal of this research is to develop tools that could identify young people who are vulnerable to developing future problems, this will ensure people get the help that they need at the right time for them. This study will use psychological assessment, online games, brain imaging and blood sampling to help improve our understanding of how and why early life experience can influence mental health, cognition, brain development and the immune system later in life.

Participants needed: 120
Trial details
Age: 18-25Biological sex: AllType: ObservationalSponsor: University of ManchesterUpdated: Feb 12, 2025Locations: 1
Eligibility criteria

Age 18-24 [+9]

You were looked after by the local authority (e.g., foster, kinship care or resi... [+3]

Status: Recruiting

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. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology and on explaining the cause of the disease from the perspective of "grandmother-mother-child" heredity. Data are collected regarding environmental exposures, lifestyle, and social support on grandmother from birth to old age. Biological samples including blood and tissue samples are collected.

Participants needed: 5,000
Trial details
Age: 36-100Biological sex: FemaleType: ObservationalSponsor: Guangzhou Women and Children's Medical CenterUpdated: Oct 1, 2024Locations: 1
Eligibility criteria

Maternal Grandmother' grandchildren delivered in Guangzhou Women and Children's... [+1]

Significant cardiovascular abnormalities [+1]

Status: Recruiting

Preterm Birth Cohort Study in Guangzhou

The Preterm Birth Cohort Study in Guangzhou (PBCSG) aims to explore the impact of genetic and environmental factors including life styles on preterm birth, to examine the interaction effect between these factors, and to follow up the short-term and long-term outcomes of preterm childrens.

Participants needed: 5,000
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Guangzhou Women and Children's Medical CenterUpdated: Feb 26, 2024Locations: 1
Eligibility criteria

Born before 37 weeks of gestation [+2]

Multiple birth [+2]

Status: Recruiting

IVF Offspring Born in Guangzhou

The IVF Offspring Born in Guangzhou Cohort Study (IVF-BIG) was established to investigate the short- and long-term effects of exposure in early life on the health of mothers and offspring in Guangzhou, China. Data are collected regarding assisted reproductive technology (ART), environmental, occupational and lifestyle exposures as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.

Participants needed: 3,000
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Guangzhou Women and Children's Medical CenterUpdated: Feb 26, 2024Locations: 1
Eligibility criteria

Pregnant women with <20 weeks of gestation [+3]

Status: Recruiting

Twins Born in Guangzhou

The 2-BIG is a twin birth cohort study located in Guangzhou, China.Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental, family and lifestyle exposures on twins from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the twins and their parents.

Participants needed: 1,000
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Guangzhou Women and Children's Medical CenterUpdated: Feb 26, 2024Locations: 1
Eligibility criteria

Live twins delivered in Guangzhou Women and Children's Medical Center [+2]

Status: Recruiting

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. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Biological samples including blood and tissue samples are also collected from the participants.

Participants needed: 30,000
Trial details
Biological sex: AllType: ObservationalSponsor: Guangzhou Women and Children's Medical CenterUpdated: Feb 26, 2024Locations: 1
Eligibility criteria

Pregnant women with <20 weeks of gestation [+2]

Status: Recruiting

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 consequences for both mother and child. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery.

Participants needed: 7,000
Trial details
Biological sex: AllType: ObservationalSponsor: Guangzhou Women and Children's Medical CenterUpdated: Sep 13, 2023Locations: 1
Eligibility criteria

Pregnant women diagnosed with gestational diabetes mellitus [+2]

Women with pre-gestational diabetes mellitus [+1]

Status: Not yet recruiting

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 age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.

Participants needed: 802
Trial details
Phase: Phase 3Age: 23-30Biological sex: AllType: InterventionalSponsor: Sharp HealthCareUpdated: Aug 4, 2023Locations: 15
Eligibility criteria

Infants at low risk for early onset sepsis-Infants born for maternal indications... [+7]