Clinical trials: Newborn Infant
Cystic Fibrosis
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
This study assesses the aerosol delivery characteristics (measured by in vivo lung deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic parameters) and safety of tobramycin inhalation solution…
- Trial name
- NCT00399945
- Testing
- Tobramycin
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis
Premature Birth
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.
- Trial name
- NCT06063122
- Testing
- smallTalk NICU Active
- Where
- 2 sites in United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Thrive Neuromedical, LLC
Glaucoma, Ocular Hypertension
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in…
- Trial name
- NCT01658839
- Testing
- Travoprost ophthalmic solution, 0.004% (new formulation)
- Volunteers
- 25 people
- Sponsor
- Alcon Research
Atopic Dermatitis
Evaluation of an Adapted Formula on Atopic Dermatitis.
The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.
- Trial name
- NCT05318300
- Testing
- tested formula with fiber, Control
- Where
- 3 sites in Belgium, France
- Volunteers
- 126 people
- Sponsor
- United Pharmaceuticals
Ankyloglossia
Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device
A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.
- Trial name
- SNIP (NCT07655895)
- Testing
- Frenectomy of anterior ankylogossia using the novel device
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Europa Life Sciences Limited
Infantile Colic
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
- Trial name
- NCT06462651
- Testing
- L. reuteri
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- BioGaia AB
Gaucher Disease, Type 2
Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE)
J3Z-MC-OJAB is an open-label, Phase 1/2, multicenter study to evaluate the safety and efficacy of single-dose LY3884961 (formerly PR001) in infants diagnosed with Type 2 Gaucher disease (GD2).
- Trial name
- NCT04411654
- Testing
- LY3884961, Methylprednisolone, Sirolimus
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Prevail Therapeutics
Cystic Fibrosis
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and…
- Trial name
- NCT04926701
- Testing
- ETD001 single dose, ETD001 multiple twice daily doses, ETD001 multiple once daily doses
- Where
- United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Cystic Fibrosis
A Study to Confirm the Long-term Safety and Effectiveness of Kalydeco in Patients With Cystic Fibrosis Who Have an R117H-CFTR Mutation, Including Pediatric Patients
The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco® (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe the long-term safety and effectiveness of…
- Trial name
- NCT02722057
- Volunteers
- 368 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Congenital Heart Defects, Blood Platelet Disorders
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet…
- Trial name
- NCT00115375
- Testing
- Clopidogrel (SR25990)
- Where
- 6 sites in United States, Belgium and 4 more
- Volunteers
- 92 people
- Sponsor
- Sanofi
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the…
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Trial name
- NCT01427712
- Testing
- Pancrelipase
- Where
- 21 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Mylan Inc.
Neonatal Jaundice
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color…
- Trial name
- NCT05521607
- Testing
- Picterus Jaundice Pro (JP)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Asthma
Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma
Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild atopic asthma.
- Trial name
- S-1226(8%) (NCT02334553)
- Testing
- S1226(8%)
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- SolAeroMed Inc.
Cystic Fibrosis
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic…
- Trial name
- NCT00420836
- Testing
- Tobramycin
- Volunteers
- 20 people
- Sponsor
- Novartis
Bacterial Infections
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
- Trial name
- NCT02527681
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Belgium and 4 more
- Volunteers
- 15 people
- Sponsor
- Basilea Pharmaceutica
Infant Nutrition
A New Adaptive Feeding Plan for Newborns
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
- Trial name
- NCT00984230
- Testing
- BSF, BSF + Lactoferrin + Probiotics, BSF + Lactoferrin + Probiotics + OS
- Where
- 6 sites in Austria, France and 1 more
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Dermatitis, Atopic
A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children
The purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability (assessed by clinical grading and parent-perception)…
- Trial name
- NCT04740892
- Testing
- Wash IP, Cream IP
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Cystic Fibrosis
A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele
This is a Phase 2 open-label, dose-escalation study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele.
- Trial name
- NCT04135495
- Testing
- ELX-02, Ivacaftor
- Where
- 10 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Eloxx Pharmaceuticals, Inc.
Neonatal Jaundice
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
- Trial name
- NCT05365399
- Testing
- smartphone-based screening tool for neonatal jaundice
- Where
- Uganda
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Cystic Fibrosis
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients
This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry.
- Trial name
- AIR-CF5 (NCT01375036)
- Where
- 31 sites in United States
- Volunteers
- 510 people
- Sponsor
- Gilead Sciences