Clinical trials: Delivery Systems
Infant, Premature, Brain Injuries
Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates
The purpose of the study is to detect structural brain changes using MRI and to correlate these findings with neurodevelopmental assessments in two-year old children previously enrolled in the NIH sponsored trial of inhaled…
- Trial name
- NCT00153855
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Dyssomnias
iCBT for Adolescents With Co-morbid Insomnia
Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load.
- Trial name
- NCT02612987
- Testing
- Internet-based Cognitive Behaviour Therapy (iCBT)
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Uppsala University Hospital
Necrotizing Enterocolitis
Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
The aim of this clinical trial is to associate paracentesis with positive metabolic derangement components for surgical determination in preterm infants with necrotizing enterocolitis.
- Trial name
- NCT06035848
- Testing
- Association of the components of metabolic derangement and paracentesis., Bell's criteria: pneumoperitoneum
- Where
- Mexico
- Volunteers
- 117 people
- Sponsor
- Gerardo Fernández Ortega
Infections, Rotavirus, Rotavirus Vaccines
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
- Trial name
- NCT01177826
- Testing
- Sample collection
- Where
- 29 sites in Belgium
- Volunteers
- 643 people
- Sponsor
- GlaxoSmithKline
Brain Injuries, Infant, Premature
SafeBoosC - a Phase II Trial
Background 25,000 infants are born extremely preterm every year in Europe. This group of infants carries a high risk of death and subsequent cerebral impairment for the infant, especially in the first 72 hours of life.
- Trial name
- SafeBoosC (NCT01590316)
- Testing
- Cerebral NIRS oximetry
- Where
- Denmark
- Volunteers
- 165 people
- Sponsor
- Gorm Greisen
Duchenne Muscular Dystrophy
A Gene Delivery Study to Evaluate the Safety and Expression of Delandistrogene Moxeparvovec in Participants Under the Age of Four With Duchenne Muscular Dystrophy (DMD)
This open-label, single-arm study will evaluate the safety and expression of delandistrogene moxeparvovec in participants with DMD. Participants will be in the study for approximately 264 weeks.
- Trial name
- ENVOL (NCT06128564)
- Testing
- delandistrogene moxeparvovec
- Where
- 7 sites in Belgium, France and 4 more
- Volunteers
- 13 people
- Sponsor
- Hoffmann-La Roche
Transfer Dysphagia, Oropharyngeal Dysphagia
Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition.
- Conditions
- Transfer Dysphagia, Oropharyngeal Dysphagia, Cricopharyngeus Muscle Dysfunction
- Trial name
- NCT04695600
- Testing
- Botulinum Toxin Type A Injection [Botox]
- Where
- India
- Volunteers
- 100 people
- Sponsor
- All India Institute of Medical Sciences
Premature Birth
Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
Prematurity birth lead to an early breaking link with the in utero environment. A special attention is brought in the neonatal intensive care units to reduce noise and lighting surrounding aiming to protect the newborn.
- Trial name
- Cardio_Sound (NCT04821011)
- Testing
- electronic stethoscope, acoustic listening of mother's heartbeats, Recording of the newborn's heart rate
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Metabolic Syndrome, Diabetes
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
This study is to compare the effects of high fat overfeeding on metabolic risk factors in children born though assisted reproduction technologies (ART) versus children conceived naturally (controls).
- Trial name
- IMPART (NCT01230632)
- Testing
- high fat overfeeding
- Where
- Australia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Adelaide
Type 1 Diabetes Mellitus
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients…
- Trial name
- T1D-DATA (NCT03228004)
- Testing
- Glooko MeterSync
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Florida
GERD, Apnea Neonatal
Effects of Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms.
Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of gastroesophageal reflux disease (GERD).
- Trial name
- FeedGERD (NCT03031288)
- Testing
- A, B
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Turin, Italy
Substance Use
FostrSpace-CASA R61/R33
The purpose of this study is to understand how an online digital health application (app) called FostrSpace can reduce substance use among youth (ages 13-20 years old) in foster care.
- Trial name
- NCT06875323
- Testing
- ECHO-FostrSpace, Informational Session
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV/AIDS
PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and…
- Trial name
- NCT04408729
- Testing
- PrEP My Way
- Where
- Kenya
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Breastfeeding, Breastfeeding Education
Improved Child Nutrition and Development Through Social Transfers
The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding.
- Conditions
- Breastfeeding, Breastfeeding Education, Breastfeeding Duration, Breastfeeding Continuation
- Trial name
- TENDER (NCT07569172)
- Testing
- Social Transfer
- Where
- Côte d’Ivoire
- Volunteers
- 1,040 people
- Sponsor
- Swiss Tropical & Public Health Institute
Intestinal Perforation, Necrotizing Enterocolitis
IRT in Infants With Intestinal Perforation
This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk.
- Trial name
- NCT01530828
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Preterm Birth Complication, Neonatal Morbidity and Mortality
Delayed Versus Immediate Cord Clamping in Preterm Birth
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping
- Trial name
- PREM-CORD (NCT07699666)
- Testing
- Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping
- Where
- Tunisia
- Volunteers
- 200 people
- Sponsor
- Faculty of Medicine of Tunis
Hiv
Pharmacy-based PrEP Delivery in Kenya
A cluster-randomized control trial (cRCT) testing different cost-sharing models for the delivery of HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) services at private pharmacies in Kenya.
- Trial name
- NCT05842122
- Testing
- Client-sustained delivery of pharmacy PrEP/PEP, Implementor-sustained delivery of pharmacy PrEP/PEP, Counselor-supported delivery of pharmacy PrEP/PEP
- Where
- 2 sites in Kenya
- Volunteers
- 5,808 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Crohn's Disease, Rheumatoid Arthritis
OTIS Cimzia Pregnancy Registry
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Conditions
- Crohn's Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- NCT01797224
- Where
- United States
- Volunteers
- 925 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Prematurity, Lactose Intolerance
Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants
Preterm infants commonly experience feeding intolerance, which can delay advancement of enteral feeding and impair early growth.
- Conditions
- Prematurity, Lactose Intolerance, Feeding Intolerance
- Trial name
- NCT07494123
- Testing
- Lactase Enzyme Supplementation
- Where
- Egypt
- Volunteers
- 124 people
- Sponsor
- Cairo University
Diffuse Intrinsic Pontine Glioma (DIPG), Brain Stem Glioma
Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)
The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes have remained dismal despite this treatment.
- Trial name
- BRAVO (NCT03396575)
- Testing
- TTRNA-DC vaccines with GM-CSF, TTRNA-xALT, Cyclophosphamide + Fludarabine Lymphodepletive Conditioning
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Florida
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