Clinical trials: Infant 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
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
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
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
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
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
Neonates and Preterm Infants, Neonates or Premature Babies
Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking.
- Trial name
- CONEXUS (NCT06940713)
- Testing
- Imaging Time
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Newborn Health, Multiple Micronutrient Deficiencies During Pregnancy
The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan.
- Conditions
- Newborn Health, Multiple Micronutrient Deficiencies During Pregnancy, Nutrition During Pregnancy, Adaptive Trial
- Trial name
- MOM-CARE (NCT07029282)
- Testing
- MMS, MMS Plus, IFA
- Where
- Pakistan
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Neurodevelopmental Disorders, Developmental Delay
Development of Motility and Cognition in Infants
PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise.
- Conditions
- Neurodevelopmental Disorders, Developmental Delay, Development, Infant, Child Development
- Trial name
- PILKE (NCT05527080)
- Testing
- physiotherapy, brace
- Where
- Finland
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
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
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
Infant, Torticollis Congenital
Comparison of the Effectiveness of Face to Face Rehabilitation and Telerehabilitation in Infants With Congenital Muscular Torticollis
Who is this study for? This study is designed for infants aged 0-6 months who have been diagnosed with Congenital Muscular Torticollis (CMT).
- Conditions
- Infant, Torticollis Congenital, Neurodevelopment Treatment, Telerehabilitation
- Trial name
- NCT06957522
- Testing
- face to face rehabilitation, telerehabilitation
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people
- Sponsor
- Istanbul University - Cerrahpasa
Pregnancy Related
Maternal Intake of Eggs and Infant Neurodevelopment
The fetal brain requires DHA, choline, lutein, and zeaxanthin (L/Z) for development, dependent on maternal intake during pregnancy. However, many pregnant women do not meet daily requirements through diet or prenatal vitamins.
- Trial name
- MIND (NCT07583186)
- Testing
- Egg Supplementation, Healthy Prenatal Diet
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Invasive Ventilation, Infant Pain
Dexmedetomidine for Invasive Ventilation In the NEOnate
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay.
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment
- Trial name
- NCT07493785
- Testing
- Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution
- Where
- 12 sites in France
- Volunteers
- 246 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Very Preterm Infants Born < 30 Weeks of Gestation
Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs).
- Trial name
- QUSBI (NCT07358819)
- Testing
- Cranial ultrasound, Brain MRI, PARCA-R questionnaire
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris