Clinical trials: Neonatal Brain Injury
Infant Colic, Postpartum Depression
Measuring and Reducing Excessive Infant Crying
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp.
- Trial name
- UTHealth THB (NCT01217658)
- Testing
- The Happiest Baby on The Block, AAP Infant Colic counseling
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- The University of Texas Health Science Center, Houston
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries.
- Trial name
- NCT02793999
- Testing
- Near-Infrared Spectroscopy (NIRS)
- Where
- 3 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Children's Hospital
Spina Bifida, Cerebral Palsy
Assessing Transition Practices for Children With Disabilities: Pathways to a Successful Adulthood
Transition to adult care is a purposeful and structured movement of youth with complex disabilities from child centered to adult oriented services. This complex and potentially challenging period requires careful planning.
- Conditions
- Spina Bifida, Cerebral Palsy, Spinal Cord Injury, Spastic Paraplegia
- Trial name
- NCT07706517
- Testing
- Chart review, Semi-structured interview
- Where
- France
- Volunteers
- 128 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Congenital Heart Disease (CHD), Hypoxic Encephalopathy
Early Detection of Brain Injury After Congenital Heart Surgery in Infants
Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury.
- Trial name
- NCT07424976
- Testing
- Observational study: blood analisys, EEG, MRI
- Where
- Slovenia
- Volunteers
- 30 people
- Sponsor
- University Medical Centre Ljubljana
Upper Extremity Impairments, Cerebral Palsy (CP)
Obi Medical Robot: Evaluating Effectiveness Related to Usability
This mixed-methods usability study evaluates the effectiveness of the Obi Gen 3 robotic feeding device in meeting user needs among providers, caregivers, and patients.
- Conditions
- Upper Extremity Impairments, Cerebral Palsy (CP), ALS - Amyotrophic Lateral Sclerosis, Rett Syndrome
- Trial name
- NCT07151950
- Testing
- One-week trial of Obi Medical device, which provides robotic assistance with feeding to persons with upper extremity impairments who are unable to self-feed in the traditional manner using utensils
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Desin LLC
Neonatal Abstinence Syndrome
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
Cerebral Palsy, Spinal Muscular Atrophy
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
For children who use a power wheelchair, a powered wheelchair standing device (PWSD) may be considered for daily use. A PWSD allows a child to electronically move between sitting and standing and can be driven in either position.
- Conditions
- Cerebral Palsy, Spinal Muscular Atrophy, Spinal Cord Injuries, Spina Bifida
- Trial name
- NCT05117827
- Testing
- Power Wheelchair Standing Device
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Grand Valley State University
Prematurity, Extreme Prematurity
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem.
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage
- Trial name
- Premalocom2 (NCT06027645)
- Testing
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Marianne Barbu-Roth
Down Syndrome, Gross Motor Delay
Up, Down, and All Around: Evaluating Mobility Devices for Young Children With Developmental Disabilities and Delays
This research study will examine young children with Down syndrome's initial experiences with mobility devices. Children's biomechanics and exploration will be quantified while they are using both an overground partial bodyweight…
- Conditions
- Down Syndrome, Gross Motor Delay, Cerebral Palsy
- Trial name
- NCT06591559
- Testing
- Permobil Explorer Mini, Portable Mobility Aid for Children (PUMA)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Washington
Neuromotor Impairments, Cerebral Palsy
The FBRI VTC Neuromotor Research Clinic
The FBRI VTC Neuromotor Research Clinic was established and opened in May of 2013 to provide intensive therapeutic services to individuals with motor impairment secondary to neuromotor disorders. It is direct by Dr.
- Conditions
- Neuromotor Impairments, Cerebral Palsy, Microcephaly, Autism
- Trial name
- NCT03325946
- Testing
- ACQUIRE Therapy
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Virginia Polytechnic Institute and State University
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Stroke, Cerebral Palsy
Modulation of Brain Plasticity After Perinatal Stroke
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects thousands of Canadian children and families.
- Trial name
- PLASTIC CHAMPS (NCT01189058)
- Testing
- Repetitive Transcranial Magnetic Stimulation (rTMS), Constraint-induced movement therapy (CIMT)
- Where
- Canada
- Volunteers
- 64 people
- Sponsor
- University of Calgary
Kidney Injury, Pre-Term
Improving Preterm Kidney Outcomes With Caffeine
This study is being done to see if additional caffeine citrate (20 milligrams per kilogram IV bolus) helps babies with low kidney oxygenation already being treated with caffeine citrate (20 milligrams per kilogram IV bolus on day…
- Trial name
- NCT07262060
- Testing
- Caffeine citrate
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- University of Wisconsin, Madison
Cerebral Palsy, Intraventricular Hemorrhage
Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%.
- Conditions
- Cerebral Palsy, Intraventricular Hemorrhage, Periventricular Leukomalacia, Pulmonary Edema
- Trial name
- BEAM (NCT00014989)
- Testing
- magnesium sulfate
- Where
- 17 sites in United States
- Volunteers
- 2,136 people
- Sponsor
- The George Washington University Biostatistics Center
Brain Injury, Seizures
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
- Conditions
- Brain Injury, Seizures, Cerebral Palsy
- Trial name
- BrainZ (NCT00516334)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Brigham and Women's Hospital
Birth Asphyxia
Asphyxia Associated Metabolite Biomarker Investigation 2
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia.
- Trial name
- AAMBI2 (NCT04714502)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 144 people
- Sponsor
- InfanDx AG
Seizures Newborn, Brain Injuries
Newborn Brain Test (NBT)
The aim of the overall project is to develop the Newborn Brain Test (NBT), a novel platform to detect abnormal brain activity in infants at birth through an automated AI assessment.
- Trial name
- NBT (NCT06580834)
- Testing
- Cergenx Wave
- Where
- Ireland
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Professor Geraldine Boylan
Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia
Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)
Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood.
- Conditions
- Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia, Brain Injury
- Trial name
- NCT05581927
- Testing
- modified Whole-Body Hypothermia, standard Whole-Body Hypothermia
- Where
- China
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Neonatal Encephalopathy, Therapeutic Hypothermia
The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are: 1.
- Conditions
- Neonatal Encephalopathy, Therapeutic Hypothermia, Brain Injuries, Child Development
- Trial name
- NCT05756296
- Testing
- Therapeutic hypothermia
- Where
- 2 sites in Canada
- Volunteers
- 198 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre