Clinical trials: Neurodevelopmental Abnormality
Extreme Prematurity, Neurodevelopmental Abnormality
Osteopathic Manipulative Medicine to Reduce Developmental Delays
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
- Trial name
- NCT04652063
- Testing
- Osteopathic Manipulative Medicine
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Iron Deficiency Anemia, Neurodevelopmental Abnormality
RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study
As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes.
- Conditions
- Iron Deficiency Anemia, Neurodevelopmental Abnormality, Autism Spectrum Disorder
- Trial name
- RAPIDIRON-KIDS (NCT05504863)
- Testing
- Ferric carboxymaltose, Iron isomaltoside, Ferric Sulfate
- Where
- 3 sites in India
- Volunteers
- 538 people
- Sponsor
- Thomas Jefferson University
Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study
The goal of this observational study is to improve the way newborn babies are cared for before, during, and after major surgery. Surgery can be very stressful on a baby's body.
- Trial name
- NEO (NCT07771478)
- Testing
- Pre-nERAS Guideline Implementation Intervention, Multifaceted Implementation of nERAS Guideline Intervention
- Where
- 3 sites in Canada, United Kingdom
- Volunteers
- 400 people
- Sponsor
- The Hospital for Sick Children
Neonatal Seizures
Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG
Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide.
- Trial name
- NCT03107507
- Testing
- Levetiracetam, Phenobarbital
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Cairo University
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Intellectual Disability, Multiple Congenital Anomaly
Whole Genome Sequencing in the Detection of Rare Undiagnosed Genetic Diseases in Children in China
To assess the indications and diagnostic efficiency of whole genome sequencing (WGS) in pediatric patients with unexplained intellectual disability/developmental delay, multiple congenital abnormalities and other rare and…
- Conditions
- Intellectual Disability, Multiple Congenital Anomaly, Rare Diseases
- Trial name
- NCT03424772
- Testing
- Whole genome sequencing
- Where
- 14 sites in China
- Volunteers
- 100 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Epilepsy; Seizure, Neuromuscular Diseases
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family…
- Conditions
- Epilepsy; Seizure, Neuromuscular Diseases, Brain Malformation, Intellectual Disability
- Trial name
- NCGENES2 (NCT03548779)
- Testing
- Pre-visit prep, usual care + exome seq
- Where
- 3 sites in United States
- Volunteers
- 548 people
- Sponsor
- University of North Carolina, Chapel Hill
Intellectual Disabilities, Congenital Anomaly
Genome Medical Sequencing for Gene Discovery
Background: A number of rare inherited diseases affect only a few patients, and the genetic causes of these conditions remain unknown.
- Conditions
- Intellectual Disabilities, Congenital Anomaly, Rare Disorders
- Trial name
- NCT01087320
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Pathology
Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients
Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other.
- Trial name
- NCT04360525
- Testing
- Reasons
- Where
- Turkey (Türkiye)
- Volunteers
- 134 people
- Sponsor
- Dr. Ersin Arslan Education and Training Hospital
Birth Defects, Multiple Congenital Anomaly
Genetic Inclusion by Virtual Evaluation
This study aims to transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving…
- Conditions
- Birth Defects, Multiple Congenital Anomaly, Neurodevelopmental Disorders
- Trial name
- GIVE (NCT05318222)
- Testing
- Whole genome sequencing (WGS)
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Patent Ductus Arteriosus, Preterm Infant
Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes
Patent ductus arteriosus (PDA), very common in preterm infants, is the delayed closure of a fetal blood vessel that limits blood flow through the lungs.
- Conditions
- Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia, Neurodevelopmental Abnormality
- Trial name
- NCT03782610
- Where
- 4 sites in United States
- Volunteers
- 526 people
- Sponsor
- Nationwide Children's Hospital
Neurodevelopmental Abnormality
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
- Trial name
- MINVIFU (NCT03621943)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1,207 people
- Sponsor
- Sharp HealthCare
Infant Development, Hypoglycemia Neonatal
Continuous Glucose Monitoring and Cerebral Oxygenation in Preterm Infants
Neonatal hypoglicaemia is associated with impaired neurodevelopment outcomes in preterm infants. Thus, hypoglicemic events should be diagnosed and treated promptly.
- Conditions
- Infant Development, Hypoglycemia Neonatal, Neurodevelopmental Abnormality
- Trial name
- Glucolight (NCT04347590)
- Testing
- Unblinded - CGM (Medtronic Guardian), Blinded - CGM (Medtronic Guardian)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- University Hospital Padova
Neurodevelopmental Abnormality
Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience
Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain.
- Trial name
- PREMA7 (NCT04607109)
- Where
- France
- Volunteers
- 238 people
- Sponsor
- Central Hospital, Nancy, France
Neurodevelopmental Abnormality
Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC.
- Trial name
- PREMOD2FU (NCT03476980)
- Testing
- Randomized to Umbilical Cord Milking at birth, Randomized to Delayed Cord Clamping at birth
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 1,200 people
- Sponsor
- Sharp HealthCare
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Premature Birth, Neurodevelopmental Disorders
Childhood Outcomes of Preterm Brain Abnormalities
Prematurely born children are at higher risk of cognitive impairments and behavioral disorders than full-term children. There is growing evidence of significant volumetric and shape abnormalities in subcortical structures of…
- Conditions
- Premature Birth, Neurodevelopmental Disorders, Brain Development Abnormality, Brain Lesion
- Trial name
- NCT03410810
- Testing
- MRI, Neurodevelopmental/Neuropsychological Assessment
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Los Angeles
Developmental Disability, Intellectual Disability
Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system.
- Conditions
- Developmental Disability, Intellectual Disability, Autism Spectrum Disorder, Congenital Anomaly
- Trial name
- NCT05295277
- Testing
- Standard of care genetic testing group
- Where
- 8 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Bionano Genomics
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
Neurodevelopmental Abnormality, Congenital Heart Disease
The Swiss Neurodevelopmental Outcome Registry for Children With CHD
Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy.
- Conditions
- Neurodevelopmental Abnormality, Congenital Heart Disease, Cardiac Disease, Intensive Care Neurological Disorder
- Trial name
- SwissORCHID (NCT05996211)
- Where
- 3 sites in Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University Children's Hospital, Zurich