Clinical trials: Infant Neurodevelopment
Preterm Infant, Infant, Premature
Pilot Study of the SENSITIVE Care Program for Preterm Infants in the Neonatal Intensive Care Unit
The goal of this clinical trial is to learn whether the Sensory Integrative Intervention (SENSITIVE) Care Program helps reduce stress and improve mother-infant interaction in preterm infants receiving care in the Neonatal…
- Conditions
- Preterm Infant, Infant, Premature, Neonatal Intensive Care Unit (NICU)
- Trial name
- SENSITIVE Care (NCT07728760)
- Testing
- SENSITIVE Care Program, Standard Neonatal Intensive Care
- Where
- Indonesia
- Volunteers
- 8 people
- Sponsor
- Gadjah Mada University
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
MLD, Krabbe Disease
Longitudinal Study of Neurodegenerative Disorders
The purpose of this study is to understand the course of rare genetic disorders that affect the brain. This data is being analyzed to gain a better understanding of the progression of the rare neurodegenerative disorders and the…
- Conditions
- MLD, Krabbe Disease, ALD, MPS I
- Trial name
- NCT03333200
- Testing
- Palliative Care, Hematopoetic Stem Cell Transplantation
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- University of Pittsburgh
Klinefelter Syndrome, Trisomy X
The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy
This study is designed to research the natural history of neurodevelopment, health and early hormonal function in infants with XXY/Klinefelter syndrome, XYY, XXX and other sex chromosome variations in an effort to identify early…
- Conditions
- Klinefelter Syndrome, Trisomy X, XYY Syndrome, XXXY and XXXXY Syndrome
- Trial name
- NCT03396562
- Testing
- Assessments of Development and Growth
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Colorado, Denver
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
Infant of Diabetic Mother
Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
The purpose of this study is to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance in infants of…
- Trial name
- NCT05467150
- Testing
- Probiotic Supplement
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Minnesota
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
Anemia, Iron Deficiency
Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment
The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth.
- Conditions
- Anemia, Iron Deficiency, Neonatal Jaundice
- Trial name
- NCT02222805
- Testing
- Early (≤30 seconds) cord clamping, Delayed (≤180 seconds) cord clamping
- Where
- Nepal
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Uppsala University
Infant Development
Assessment of Motor Development With a Wearable in Rural and Low-income Settings
The MaMa study aims to assess feasibility and validity of an infant wearable in a rural settings. Altogether N~100 infants will be recruited and measured multiple times at homes from age 6 months to age 18 months.
- Trial name
- MaMa (NCT05782673)
- Testing
- wearable MAIJU for motor assessment
- Where
- 4 sites in Finland, Malawi
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Infant Development
A Neurocognitive and Immunological Study of a New Formula for Healthy Infants
To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.
- Trial name
- COGNIS (NCT02094547)
- Testing
- New infant formula, Standard infant formula, Breastfeeding
- Where
- Spain
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Laboratorios Ordesa
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
Sleep, Neurodevelopmental Disorders
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
It is well known that sleep is essential for brain development and learning. Infants require extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for optimizing physical growth.
- Trial name
- BabySMART (NCT03381027)
- Testing
- Baby Massage
- Where
- Ireland
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- University College Cork
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
Anaesthesia, Neurodevelopment
Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood
This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia on neurocognitive outcomes in early childhood by analyzing neurocognitive data already obtained from the local prospective observational…
- Trial name
- PANO (NCT02184780)
- Where
- Singapore
- Volunteers
- 468 people
- Sponsor
- KK Women's and Children's Hospital
Microbiome, Neurodevelopment Outcome
The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury
Recent advances in neonatal intensive care have dramatically increased the survival rate of extremely premature infants but the number of survivors with severe morbidity and lifelong neurodevelopmental impairment remains high.
- Conditions
- Microbiome, Neurodevelopment Outcome, Immunology
- Trial name
- PreMiBraIn (NCT03213275)
- Testing
- Microbiome Sequencing, Neurophysiologic Assessment, Immunological test
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Medical University of Vienna
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
Neurobehavioral Manifestations
Prophylaxis Against Malaria to Enhance Child Development (PROTECT Study)
Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical immunity to malaria, malaria infection in…
- Trial name
- PROTECT (NCT02557425)
- Testing
- No intervention in PROTECT
- Where
- Uganda
- Volunteers
- 272 people
- Sponsor
- Indiana University
Infant, Small for Gestational Age
SURF, Neurodevelopment, Growth Study in SGA Infants
The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of…
- Trial name
- NCT04360967
- Testing
- Standard Formula, Nutrient-enriched Formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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