Clinical trials: Newborn Infant
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00981214
- Testing
- EUR-1008 (APT-1008)
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to <24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
- Trial name
- NCT04235140
- Testing
- LUM/IVA
- Where
- 23 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hemolytic Disease of the Fetus and Newborn
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN).
- Trial name
- NCT03842189
- Testing
- M281
- Where
- 19 sites in United States, Australia and 7 more
- Volunteers
- 25 people
- Sponsor
- Janssen Research & Development, LLC
Interstitial Lung Disease, COPD
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as…
- Conditions
- Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis
- Trial name
- GUARDIANLUNG (NCT04930289)
- Testing
- LungGuard, BAROGuard
- Where
- 15 sites in United States, Belgium
- Volunteers
- 3,500 people
- Sponsor
- Paragonix Technologies
Feeding Patterns, Feeding; Difficult, Newborn
Neoneur Feeding System Functionality in the Clinic
Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial
- Conditions
- Feeding Patterns, Feeding; Difficult, Newborn, Feeding Disorder Neonatal
- Trial name
- NN200 (NCT05525091)
- Testing
- Feeding Evaluation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neoneur LLC
Cystic Fibrosis
A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to…
- Trial name
- NCT00680316
- Testing
- Dornase alfa
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Colic
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.
- Trial name
- BACTECOLIC (NCT05052476)
- Testing
- Bactecal® D Liquid
- Where
- Belgium
- Volunteers
- 68 people
- Sponsor
- Astel Medica
Cystic Fibrosis
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2…
- Trial name
- NCT02797132
- Testing
- LUM/IVA
- Where
- 20 sites in United States, Canada
- Volunteers
- 62 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy
SurePulse Oximeter - a Targeted Oxygenation Observation
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation).
- Trial name
- SPO-TOO (NCT05756816)
- Testing
- SurePulse VSP, SurePulse VS
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Surepulse Medical Limited
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product…
- Trial name
- NCT01100606
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Prader-Willi Syndrome
Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome
- Trial name
- NCT02204163
- Testing
- Eutropin, Genotropin
- Where
- 3 sites in South Korea
- Volunteers
- 34 people
- Sponsor
- LG Life Sciences
Cystic Fibrosis
Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a…
- Trial name
- NCT00043316
- Testing
- interferon gamma-1b
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- InterMune
Saccular and Fusiform Aneurysms, Pseudoaneurysm
Targeting Real World Usage In Stroke Treatment
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC…
- Conditions
- Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection, Perforation
- Trial name
- TRUST (NCT07474935)
- Testing
- Aneurysm Treatment with a Neurovascular Flow Diverter, Dissection Treatment with a Neurovascular Flow Diverter, Perforation Treatment with a Neurovascular Flow Diverter
- Where
- 13 sites in France, Germany and 3 more
- Volunteers
- 5,000 people
- Sponsor
- Phenox GmbH
Cystic Fibrosis
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic…
- Trial name
- NCT01225211
- Testing
- Lumacaftor, Ivacaftor
- Where
- 55 sites in United States, Australia and 5 more
- Volunteers
- 312 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Newborn Complication, Newborn Morbidity
Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya.
- Trial name
- NCT05728307
- Testing
- neoGuard vital signs monitor
- Where
- Kenya
- Volunteers
- 3,000 people
- Sponsor
- Assumpta Solome Nantume
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants with EPI.
- Conditions
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF), Pancreatic Enzyme Abnormality, Pancreatic Diseases
- Trial name
- EPIC (NCT07559175)
- Testing
- NHS7108, Zenpep®
- Where
- 39 sites in United States, Bulgaria and 5 more
- Volunteers
- 66 people
- Sponsor
- Aimmune Nestlé Health Science US R&D, LLC
Cystic Fibrosis
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene.
- Trial name
- RM/NEB-03-10 (NCT01337219)
- Testing
- Tobramycin
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Erempharma
Cystic Fibrosis
Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)
The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who…
- Trial name
- DEFY (NCT00846781)
- Testing
- Denufosol tetrasodium Inhalation Solution
- Volunteers
- 308 people
- Sponsor
- Merck Sharp & Dohme LLC