Clinical trials: Newborn Infant
Neonatal Jaundice
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
- Trial name
- allphones (NCT05955144)
- Testing
- Picterus JP
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Pulmonary Cystic Fibrosis
Home Airway Clearance in CF Patients
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.
- Trial name
- HomeCareSIMEOX (NCT04096664)
- Testing
- SIMEOX
- Where
- 20 sites in France
- Volunteers
- 143 people
- Sponsor
- Physio-Assist
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Cystic Fibrosis
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.
- Trial name
- NCT03125395
- Testing
- LUM/IVA
- Where
- 20 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
Establish Normative pH Values in Neonates
Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
Objectives: 1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor 2.
- Trial name
- NCT02279264
- Testing
- RightSpot Infant pH Indicator
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- RightBio Metrics
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation
This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic…
- Trial name
- SNO4 (NCT02275936)
- Testing
- N91115
- Where
- 19 sites in United States
- Volunteers
- 51 people
- Sponsor
- Nivalis Therapeutics, Inc.
Cystic Fibrosis, Pancreatic Insufficiency
Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI
The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF)…
- Trial name
- NCT00406536
- Testing
- Lym-X-Sorb powder
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Avanti Polar Lipids, Inc.
Cystic Fibrosis Lung
4D-710 in Adult Patients With Cystic Fibrosis
This is a Phase 1/2 multicenter, open-label, single dose trial of 4D-710 investigational gene therapy in adults with cystic fibrosis.
- Trial name
- CF (NCT05248230)
- Testing
- 4D-710
- Where
- 20 sites in United States
- Volunteers
- 30 people
- Sponsor
- 4D Molecular Therapeutics
Functional Gastrointestinal Disorders, Infantile Colic
Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
- Conditions
- Functional Gastrointestinal Disorders, Infantile Colic, Functional Constipation
- Trial name
- NCT04944628
- Testing
- Probiotic
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- AB Biotics, SA
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase.
- Trial name
- NCT02279498
- Testing
- Liprotamase, porcine (pig) PERT
- Where
- 54 sites in United States, Canada and 5 more
- Volunteers
- 128 people
- Sponsor
- Anthera Pharmaceuticals
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Ichthyosis
The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis
This is a randomized, double-blind and vehicle-controlled Phase III study to evaluate the safety and efficacy of topical TMB-001 0.05% ointment for the treatment of congenital ichthyosis (CI) in subjects with either the RXLI or…
- Trial name
- ASCEND (NCT05295732)
- Testing
- TMB-001, Matching Vehicle
- Where
- 35 sites in United States, Canada and 3 more
- Volunteers
- 153 people
- Sponsor
- LEO Pharma
Cystic Fibrosis
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
- Trial name
- NCT00434278
- Testing
- Dornase alfa
- Where
- 40 sites in United States
- Volunteers
- 27 people
- Sponsor
- Genentech, Inc.
Cystic Fibrosis
Study of the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis and the G551D Mutation
Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The encoded protein, CFTR, is an epithelial chloride ion channel responsible for aiding in the regulation of salt…
- Trial name
- NCT01161537
- Testing
- VX-770
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary…
- Trial name
- NCT00757237
- Testing
- Aztreonam for Inhalation Solution (AZLI), Tobramycin Inhalation Solution (TIS)
- Where
- 92 sites in United States, Austria and 11 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
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
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01473264
- Testing
- recombinant human CC10 (rhCC10)
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Clarassance, Inc.
Netherton Syndrome
Natural History of Netherton Syndrome
The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).
- Trial name
- NCT05902663
- Where
- 4 sites in United States, Italy
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim