Clinical trials: Infant Neurodevelopment, active
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
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
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
Heart Defects, Congenital, Anxiety in Pregnancy
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a…
- Conditions
- Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological
- Trial name
- HeartGPS (NCT06175104)
- Testing
- HeartGPS
- Where
- 4 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Punctate White Matter Lesions, Neurodevelopmental Outcomes
MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury
The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML).
- Conditions
- Punctate White Matter Lesions, Neurodevelopmental Outcomes, Preterm Infants
- Trial name
- NCT07860749
- Where
- 10 sites in China
- Volunteers
- 260 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Infantile Colic, Breast Feeding
The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants
Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system.
- Conditions
- Infantile Colic, Breast Feeding, Atopic Dermatitis, Infant Formula
- Trial name
- NCT05992493
- Where
- Taiwan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Cheng-Kung University Hospital
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
Newborn; Vitality, Premature Infants
Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment
Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and…
- Conditions
- Newborn; Vitality, Premature Infants, Infant Development
- Trial name
- BABYCRY_1000 (NCT06332521)
- Testing
- Acoustic signal analysis method
- Where
- France
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Premature Infant
Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care…
- Trial name
- NCT03345069
- Where
- United States
- Volunteers
- 393 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Chronic Idiopathic Constipation (CIC)
A Study of Prucalopride in Breastfeeding Women With Constipation
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk.
- Trial name
- NCT04838522
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Takeda
Prematurity Complications, Neurodevelopment Outcome
Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births…
- Conditions
- Prematurity Complications, Neurodevelopment Outcome, Prematurity
- Trial name
- OutbornTRANSF (NCT07580859)
- Testing
- Usual Care
- Where
- France
- Volunteers
- 627 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
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
Premature Birth, Risk
The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period.
- Conditions
- Premature Birth, Risk, Early Intervention
- Trial name
- MIT-PB (NCT05319158)
- Testing
- MIT-PB, movement imitation therapy for preterm.
- Where
- 3 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
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
Iodine Deficiency, Nutrition Poor
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency.
- Conditions
- Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding
- Trial name
- EMECHAT (NCT05901766)
- Testing
- UNIMMAP Multiple Micronutrient Supplement
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Brown University
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