Clinical trials: Development, Infant, open to volunteers
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
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
Self Efficacy, Infant Development
Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU
Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden.
- Conditions
- Self Efficacy, Infant Development, eHealth, Mental Health Wellness 1
- Trial name
- NCT05853666
- Testing
- CNH+
- Where
- Canada
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Prematurity
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age.
- Trial name
- SPIN-NA (NCT07169110)
- Testing
- SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
- Where
- France
- Volunteers
- 35 people
- Sponsor
- University Hospital, Toulouse
Autism, Autism Spectrum Disorder
Word Learning From Parentese in Autistic Children
The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are…
- Conditions
- Autism, Autism Spectrum Disorder, Neurodevelopmental Disorders
- Trial name
- NCT06649916
- Testing
- Parentese Speech, Adult Registered Speech
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas at Dallas
Duchenne Muscular Dystrophy (DMD)
The Baby Duchenne Study: Characterizing Developmental and Clinical Outcomes in the First Three Years in Children With Duchenne Muscular Dystrophy
The aim of the BABY DUCHENNE study is to evaluate the natural history and characterize the early clinical outcomes in very young children (0-3 years) with Duchenne muscular dystrophy (DMD) identified by newborn screening programs.
- Trial name
- BABY DUCHENNE (NCT07092540)
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- University of Rochester
Vitamin B 12 Deficiency
Early Infant Micronutrition and Development
Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway.
- Trial name
- RART (NCT05005897)
- Testing
- Cyanocobalamin
- Where
- Norway
- Volunteers
- 600 people
- Sponsor
- Sykehuset Innlandet HF
Hip Dysplasia, Developmental
Efficacy Study of DeepDDH System in Screening Infants with Developmental Dysplasia of the Hip (DDH)
To ascertain the efficacy of the DeepDDH system, a deep learning framework, in enhancing diagnostic accuracy and curtailing follow-up intervals for infants undergoing screening for developmental dysplasia of the hip (DDH), the…
- Trial name
- NCT06765525
- Testing
- Junior sonographer measurement of DDH, Senior sonographer measurement of DDH, Automated annotation of the DDH measurement through deep learning
- Where
- China
- Volunteers
- 1,976 people
- Sponsor
- RenJi Hospital
Development Delay, Motor Skills Disorders
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated…
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant
- Trial name
- NCT07878819
- Testing
- Remote Family-Centered Early Intervention Program, Standard Information and Routine Follow-up
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bengisu Boz Gürboğa
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
Premature Infants, Very Low Birth Weight Infants
The Video System to Provide a Developmental Training Guide for Preterm Infants
This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy…
- Trial name
- NCT06965842
- Testing
- Parent-centered developmental training
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Hospital
Developmental Dysplasia of the Hip
Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
This study evaluates the feasibility and utility of contrast-enhanced ultrasound to provide real-time assessment of blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip.
- Trial name
- NCT03107520
- Testing
- Intraoperative contrast-enhanced ultrasound (CEUS), Lumason
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Children's Hospital of Philadelphia
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral…
- Conditions
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
- Trial name
- PreVNT (NCT03906435)
- Testing
- Cognitive Behavioral Therapy
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Autism, Prematurity
Eye Tracking and Autism in Former Preterm Infants
This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP).
- Trial name
- NCT07764822
- Testing
- Eye-tracking device
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Indiana University
Motor Delay, Infant Development
Wearable Sensor Toolkit for Infant Motor Development
The purpose of this study is to develop and test a fully automated, wireless sensor-based toolkit for infants that can capture early indicators (0-3 months) of motor deficits during activities of daily life and track motor…
- Conditions
- Motor Delay, Infant Development, Motor Development of Premature Infants, Motor Coordination or Function; Developmental Disorder
- Trial name
- NCT07866495
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Shirley Ryan AbilityLab
Fragile X Syndrome, Angelman Syndrome
Parent and Infant Inter(X)Action Intervention (PIXI)
The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or…
- Conditions
- Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, Dup15Q Syndrome
- Trial name
- NCT03836300
- Testing
- Parent-Infant Inter(X)action Intervention (PIXI)
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- RTI International
Retinopathy of Prematurity
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed…
- Trial name
- NCT05558059
- Testing
- Handheld Optical Coherence Tomography with OCT Angiography
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Duke University
Healthy, Healthy Nutrition
The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial
The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B.
- Trial name
- BEGIN (NCT06452199)
- Testing
- B. infantis
- Where
- 2 sites in Denmark
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Pregnancy Related, Infant Development
Maternal Abdominal Morphology Assessment
Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy.
- Conditions
- Pregnancy Related, Infant Development, Pancreas, Diabetes
- Trial name
- MAMA (NCT06784674)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University of Texas at Austin
Lungs; Developmental Disorder
Use of Hyperpolarized 129Xe MR Lung Imaging in Infants
Abnormalities of the lungs are common in newborns and can include aspiration or infectious pneumonia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), pulmonary hypertension (PH), congenital diaphragmatic…
- Trial name
- NCT04995562
- Testing
- 129Xe
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati