Clinical trials: Infants
Cystic Fibrosis
Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild…
- Trial name
- NCT02423447
- Testing
- Electro-Flo Intervention, G5 Intervention
- Volunteers
- 25 people
- Sponsor
- Stanford University
Postnatal Growth Restriction, Necrotizing Enterocolitis
Human Milk-derived Fortification in Preterm Infants
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW)…
- Trial name
- NCT05228847
- Testing
- Human milk-derived HMF, bovine milk-derived HMF
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- University of Calgary
Cystic Fibrosis, Covid19
The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic
The aim of this study is to evaluate the peripheral muscle function, sleep disorders and physical activity level in children with cystic fibrosis who are physically inactive at home due to social isolation and to examine the…
- Conditions
- Cystic Fibrosis, Covid19, Social Isolation
- Trial name
- NCT04742049
- Testing
- Telerehabilitation-based, Follow-up based
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Hacettepe University
Very Low Birth Weight Infant
The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.
- Trial name
- NCT06550440
- Testing
- family integrated care
- Where
- China
- Volunteers
- 1,255 people
- Sponsor
- Children's Hospital of Fudan University
Retinopathy of Prematurity (ROP)
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- (BabySTEPS3) (NCT07738874)
- Testing
- Ultra-widefield Optical Coherence Tomography (UWF-OCT), Wide-field ophthalmic imaging system
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Duke University
Acute Myeloid Leukemia (AML)
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children.
- Trial name
- NCT06679582
- Testing
- Luveltamab tazevibulin
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 1 people
- Sponsor
- Sutro Biopharma, Inc.
Tetanus, Diphtheria
Confirmatory Study of BK1310 in Healthy Infants
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT03891758
- Testing
- DPT-IPV-Hib, Hib vaccine, DPT-IPV
- Where
- Japan
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Jaundice, Neonatal, Neonatal Hyperbilirubinemia
Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
Phototherapy has served as a primary treatment for hyperbilirubinemia in newborn populations. The light emitted through phototherapy interacts with bilirubin at the skin level to transform it into water-soluble products…
- Conditions
- Jaundice, Neonatal, Neonatal Hyperbilirubinemia, Neonatal Disorder
- Trial name
- NCT03599258
- Testing
- Skylife, Standard Therapy
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- HonorHealth Research Institute
Pain
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
- Trial name
- NCT00533468
- Testing
- Lidocaine Cream 4%
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- State University of New York at Buffalo
Microbial Colonization, Ventilator Associated Pneumonia
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care.
- Trial name
- NCT05167318
- Testing
- frequent standardized oral care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Florida
Urea Cycle Disorder, Inborn Errors of Metabolism
A Collection of Case Studies in Infants With UCD to Evaluate Infant Growth and the Safety of a New Medical Food for UCD
Original study: Study aims to enroll 3-5 children with confirmed Urinary Cycle Disorder (UCD). Subjects meeting the inclusion and exclusion criteria are included during the baseline visit.
- Trial name
- NCT03911089
- Testing
- UCD Anamix Infant
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Nutricia Research
Pediatrics, Neurological Abnormality
Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE)
The American Academy of Pediatrics defines infants at risk as those with preterm birth, special health care needs, family risk factors, and those at risk of early death.
- Conditions
- Pediatrics, Neurological Abnormality, Neurodevelopment Outcome
- Trial name
- BRIEF-HINE (NCT07182474)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Healthy Infants
Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements
This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age
- Trial name
- NCT07630584
- Testing
- Probiotic dietary supplement
- Where
- 2 sites in Philippines
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Crohn Disease
Mother-to-Infant Transfer of Bacteriome, Fungome, Virome, and Metabolome in Health and Crohn's Disease
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.
- Trial name
- NCT05112497
- Testing
- No intervention procedure
- Where
- Hong Kong
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Prader-Willi Syndrome
PWS European Blood Bank for Infants and Controls From 0 to 48 Months
The present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS.
- Trial name
- NCT02529085
- Testing
- blood samples
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Infant, Extremely Premature, Acute Lung Injury
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo.
- Conditions
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity, Budesonide
- Trial name
- STOPCLD (NCT05364385)
- Testing
- Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Arizona
Respiratory Distress Syndrome
High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)
Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks gestation; surfactant and mechanical ventilation have been the standard treatment.
- Trial name
- NCT01496508
- Testing
- mechanical ventilation (SLE 5000, Servo-i-Maquet)
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Zhengzhou Children's Hospital, China
Preg Complications: Hemorrhagic, Infant, Premature, Diseases
Maternal & Infant Morbidity and Mortality
The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health.
- Conditions
- Preg Complications: Hemorrhagic, Infant, Premature, Diseases, Preg Complications: Hemorrhagic Intervillous of Placenta, Preg Complications: Bleeding From Female Genital Tract
- Trial name
- NCT06145568
- Testing
- Pregnant Women
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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