Clinical trials: Infants, open to volunteers
Respiratory Syncytial Virus Infections
A Study of BLB-201 RSV Vaccine in Infants and Children
This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10^6 PFU and 10^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type…
- Trial name
- NCT05655182
- Testing
- PIV5-vectored RSV Vaccine (BLB-201) Low Dose, PIV5-vectored RSV Vaccine (BLB-201) High Dose
- Where
- 18 sites in United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Blue Lake Biotechnology Inc.
Speech
Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
The goal of this study is to investigate the preferential responses of speech neural systems in infants. The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with…
- Trial name
- AV-SSR-I (NCT06282289)
- Testing
- Magnetoencephalography (MEG), Cognition development questionnaire
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Cow Milk Protein Allergy, FPIES
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based…
- Trial name
- PANDA (NCT07592182)
- Testing
- Oral Food Challenge V2, Product administration between V4 and V5, Oral Food Challenge V3
- Volunteers
- 55 people
- Sponsor
- Lactalis
Netherton Syndrome
Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
The goal of this clinical trial (via an expanded access Treatment Protocol) is to learn if QRX003 (an investigational drug) applied topically to the skin (including up to the entire body [except the scalp]) works to treat the…
- Trial name
- NCT06953466
- Testing
- QRX003, 4% Lotion
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Quoin Pharmaceuticals
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation (3849 +10kb C-->T).
- Trial name
- NCT06429176
- Testing
- SPL84
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- SpliSense Ltd.
Spinal Muscular Atrophy Type I
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1
GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1.
- Trial name
- NCT07070999
- Testing
- GB221
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Gemma Biotherapeutics
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life
- Trial name
- MESK-2 (NCT07342972)
- Testing
- Goat milk-based infant formula, Cow's milk-based infant formula
- Where
- Saudi Arabia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Growth, Neonates
Improving Artificial Intelligence-derived Algorithms for Estimating Length and Weight in NEonateS and infanTs up to 6 Months of Age (NEST)
The NEST study is a prospective, observational research study designed to collect clinical measurements and image data to develop and evaluate artificial intelligence (AI)-derived algorithms for estimating anthropometric…
- Conditions
- Growth, Neonates, AI (Artificial Intelligence)
- Trial name
- NEST (NCT07514182)
- Where
- Singapore
- Volunteers
- 60 people
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Pneumococcal Immunization, Healthy Volunteers
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies"…
- Trial name
- NCT07348692
- Testing
- PCV21 vaccine, 20vPCV licensed vaccine
- Where
- 25 sites in United States, Honduras and 2 more
- Volunteers
- 2,195 people, healthy volunteers welcome
- Sponsor
- Sanofi
Intestinal Malabsorption
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
- Trial name
- NCT05904626
- Testing
- ELGN-2112
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Elgan Pharma Ltd.
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Phase 2 Study to Assess the Safety and Efficacy of ANG003
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI).
- Trial name
- NCT07450547
- Testing
- ANG003 Dose A, ANG003 Dose B, Creon
- Where
- 28 sites in United States
- Volunteers
- 113 people
- Sponsor
- Anagram Therapeutics, Inc.
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF)
Study With Phage for CF Subjects With Pseudomonas Lung Infection
The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects.
- Trial name
- NCT06998043
- Testing
- BX004
- Where
- 14 sites in United States
- Volunteers
- 63 people
- Sponsor
- BiomX Ltd
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)
Microbiota, Gut Microbiome
Flourish: Exploring the Early Infant Gut Microbiome
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months…
- Conditions
- Microbiota, Gut Microbiome, Eczema, Microbiome
- Trial name
- NCT07333482
- Testing
- Tailored Recommendations, Consult Call, Educational Email Series
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Seeding Inc
Cow's Milk Protein Allergy
Hydrolysed Rice Formula Study
This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day…
- Trial name
- NCT06288503
- Testing
- Hydrolysed Rice Protein Formula, Cow's Milk Based Extensively Hydrolysed Formula
- Where
- 2 sites in United Kingdom
- Volunteers
- 86 people
- Sponsor
- Nutricia UK Ltd
Persistent Pulmonary Hypertension of Newborn
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).
- Trial name
- NEPHY (NCT06499363)
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- Ferrer Internacional S.A.
Multiple Sclerosis
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the…
- Trial name
- NCT05170126
- Where
- 3 sites in United States, Germany
- Volunteers
- 1,182 people
- Sponsor
- Bristol-Myers Squibb
Infant ALL
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant…
- Trial name
- NCT07867509
- Testing
- Infant Formula, Breastfeeding
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
SpO2, Nasal Alar Collapse, Bilateral
Project Mountain - Comparing SpO2 and SaO2 for Accuracy
The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology.
- Conditions
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement
- Trial name
- NCT06372106
- Testing
- SaO2 Sampling
- Where
- 5 sites in United States
- Volunteers
- 560 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Pertussis, Diphtheria
Study of BK1803 in Healthy Infants
This study is a phase 3, randomized, observer-blinded, active-controlled, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants aged 2 months to less than 7 months.
- Conditions
- Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT07793513
- Testing
- BK1803, GOBIK Aqueous Suspension Syringes, Bimmugen® Injection
- Where
- 33 sites in Japan
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation