Clinical trials: Neonatal Brain Injury
Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia
Palliative Care Needs of Children With Rare Diseases and Their Families
The palliative care needs of family caregivers of children with rare diseases and their children are largely unmet, including the need for support to prepare for future medical decision making.
- Conditions
- Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia, Asparagine Synthetase Deficiency, CHARGE Syndrome
- Trial name
- FACE-Rare (NCT06938542)
- Testing
- Family Centered pediatric palliative care for family caregivers of children with rare diseases.
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Spastic Diplegia, Periventricular Leukomalacia
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia
This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.
- Trial name
- NCT03672877
- Testing
- Intensive exercise
- Where
- 2 sites in Canada
- Volunteers
- 60 people
- Sponsor
- University of Alberta
Preterm Birth, Ventilator Lung; Newborn
Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in…
- Trial name
- Kangaroo (NCT04865302)
- Testing
- SSC
- Where
- Austria
- Volunteers
- 43 people
- Sponsor
- Medical University of Graz
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Cerebral Palsy, Neurologic Disorder
Post-operative Lite Run Study
Lite Run is a new assistive device that may have FDA listing as a Class I device by mid 2017 based on clinical testing of adults, independent agency testing and in-house evaluations.
- Conditions
- Cerebral Palsy, Neurologic Disorder, Chromosome Abnormality, Spina Bifida
- Trial name
- NCT03135145
- Testing
- Lite Run Gait Trainer, Usual Treatments
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Gillette Children's Specialty Healthcare
Cerebral Palsy, Brachial Plexus Palsy
Turkish Version of Hand-Use-at-Home Questionnaire
To investigate the validity and reliability of the Turkish Version of parent-rated Hand-Use-at- Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy.
- Trial name
- NCT04243590
- Testing
- Hand-Use-at-Home Questionnaire (HUH), Pediatric Outcome Data Collection Instrument (PODCI), Children's Hand-Use Experience Questionnaire (CHEQ)
- Where
- Turkey (Türkiye)
- Volunteers
- 67 people
- Sponsor
- Marmara University
Hypoxia-Ischemia, Brain, Periventricular Leukomalacia
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
The investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls.
- Trial name
- NCT00375908
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Trial name
- NCT05590676
- Testing
- Metformin Hydrochloride
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- The Hospital for Sick Children
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
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Urea Cycle Disorder, Organic Acidemia
Systemic Biomarkers of Brain Injury From Hyperammonemia
Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and…
- Conditions
- Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I
- Trial name
- NCT04602325
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's National Research Institute
Muscular Dystrophies, Spinal Muscular Atrophy
Schulze Muscular Dystrophy Ability Clinical Study
The primary objective of the Schulze study is to evaluate the function of the upper limbs of subjects diagnosed with neuromuscular disorders, with and without use of the Abilitech Assist device in the clinic and home…
- Conditions
- Muscular Dystrophies, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy, Limb Girdle Muscular Dystrophy
- Trial name
- NCT05409079
- Testing
- Abilitech Assist
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- AbiliTech Medical Inc.
Hypoxic-Ischemic Encephalopathy
A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth
Perinatal asphyxia is a significant health problem with an incidence of 1 to 8 per 1,000 live births and can lead to serious morbidity and mortality during the neonatal period.
- Trial name
- NCT07292220
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mustafa Gürkan
Gaucher Disease
A Study to Evaluate and Characterize the Effect of Pharmacological Chemicals on Blood From Patients With Gaucher Disease
Gaucher disease is a lysosomal storage disorder resulting from a deficiency in the key enzyme b-glucocerebrosidase (GCase). This enzyme is responsible for breaking down a specialized type of fat molecule, known as…
- Trial name
- NCT00465062
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Infant Respiratory Distress Syndrome, Ventilator Lung; Newborn
Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants
Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or…
- Trial name
- CLAC-4 (NCT03163108)
- Testing
- Closed-loop automatic oxygen control (CLAC) fast in addition to RMC, Closed-loop automatic oxygen control (CLAC) slow in addition to RMC
- Where
- 2 sites in Germany
- Volunteers
- 19 people
- Sponsor
- University Hospital Tuebingen
Peri-operative Injury, Newborn, Infant, Disease
Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery
The purpose of this study is to assess whether peri-operative period in neonates and infants is associated with an increase in blood biomarkers, specific for neuronal injury, and to correlate them with clinical variables and…
- Trial name
- NEMARKO (NCT02423369)
- Testing
- Cerebral near infrared spectroscopy, S-100B protein in serum, NSE protein in serum
- Where
- Lithuania
- Volunteers
- 49 people
- Sponsor
- Lithuanian University of Health Sciences
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
Hypoxia, Brain, Hypoxia-Ischemia, Brain
Home Stimulation for Brain-Asphyxiated Infants
This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities.
- Trial name
- NCT00006516
- Testing
- Infant stimulation
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Prematurity, Bronchopulmonary Dysplasia
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
- Conditions
- Prematurity, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- NOVA2 (NCT00515281)
- Testing
- inhaled nitric oxide, oxygen
- Where
- United States
- Volunteers
- 273 people
- Sponsor
- University of Chicago
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