Clinical trials: Newborn Infant
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Cystic Fibrosis in Children
The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health.
- Trial name
- NCT03522480
- Testing
- Jamboxx Respiratory Therapy Device, Autogenic Draining Training
- Where
- United States
- Sponsor
- My Music Machines Inc.
Persistent Pulmonary Hypertension of the Newborn
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).
- Trial name
- NCT02261883
- Testing
- IV Remodulin
- Where
- 14 sites in United States
- Volunteers
- 42 people
- Sponsor
- United Therapeutics
Cystic Fibrosis
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.
- Trial name
- NCT03969888
- Testing
- ABBV-3067, ABBV-2222
- Where
- 51 sites in United States, Belgium and 10 more
- Volunteers
- 78 people
- Sponsor
- AbbVie
Persistent Fetal Circulation Syndrome
Sildenofil in Persistent Pulmonary Hypertension in Newborns
This study hopes to evaluate the effectiveness of early combined use of Sildenafil and nitric oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or hypoxemic respiratory failure and assess whether this…
- Trial name
- Sildeno (NCT01558466)
- Testing
- Sildenafil, diluent
- Where
- Qatar
- Volunteers
- 100 people
- Sponsor
- Hamad Medical Corporation
Pulmonary Hypertension of Newborn
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow.
- Trial name
- PaTTerN (NCT03132428)
- Testing
- INOmax
- Where
- 30 sites in United States
- Volunteers
- 140 people
- Sponsor
- Mallinckrodt
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
Cystic Fibrosis
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation
This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del…
- Trial name
- NCT03537651
- Testing
- TEZ/IVA, IVA
- Where
- 55 sites in United States, Australia and 9 more
- Volunteers
- 130 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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.
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Retinopathy of Prematurity
Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
This study was an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
- Trial name
- NCT05304949
- Testing
- Lucentis
- Where
- 6 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
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
Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis
The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects.
- Trial name
- NCT00570349
- Testing
- Nitric Oxide for Inhalation, Nitrogen
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Image Evaluation
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- Firefly (NCT02232009)
- Testing
- 3.0 T Neonatal MRI Scanner
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- GE Healthcare
Antioxidant Role of the Lutein in Preterm Newborn
Early Administration of the Lutein/Zeaxanthin in Premature Newborns
Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system…
- Trial name
- NCT03340103
- Testing
- LUTEIN ofta 0,5 gocce
- Where
- 4 sites in Italy
- Sponsor
- Sooft Italia
Cystic Fibrosis, Lung Infection Bacterial
Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
This prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the AtbFinder® in persons with cystic fibrosis.
- Trial name
- NCT05584982
- Testing
- AtbFinder
- Volunteers
- 35 people
- Sponsor
- TGV-Dx
Pulmonary Hypertension, Familial Persistent, of the Newborn
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
- Trial name
- NCT01720524
- Testing
- iv sildenafil
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 59 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid…
- Conditions
- Cholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency, LAL-Deficiency
- Trial name
- NCT01488097
- Testing
- sebelipase alfa
- Where
- 10 sites in United States, Canada and 3 more
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients
The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.
- Trial name
- DPM-PK-102 (NCT00792714)
- Testing
- Mannitol
- Where
- 4 sites in Australia, United Kingdom
- Volunteers
- 18 people
- Sponsor
- Syntara
Cystic Fibrosis
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
- Trial name
- NCT04043806
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 97 sites in United States, Australia and 9 more
- Volunteers
- 458 people
- Sponsor
- Vertex Pharmaceuticals Incorporated