Clinical trials: Newborn Infant
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
Immune Deficiency Disorders, Severe Combined Immunodeficiency
Immune Disorder HSCT Protocol
This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders.
- Conditions
- Immune Deficiency Disorders, Severe Combined Immunodeficiency, Chronic Granulomatous Disease, X-linked Agammaglobulinemia
- Trial name
- NCT01821781
- Testing
- Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Washington University School of Medicine
Infant, Premature, Neonatal Respiratory Distress
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Trial name
- MODERATION Neo (NCT05030012)
- Testing
- Automated Control, Manual Control
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vapotherm, Inc.
Cystic Fibrosis
Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
- Trial name
- KONDUCT (NCT01614457)
- Testing
- Ivacaftor
- Where
- 31 sites in United States, United Kingdom
- Volunteers
- 70 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the…
- Trial name
- NCT02412111
- Testing
- Ivacaftor, Tezacaftor/Ivacaftor
- Where
- 68 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Colic, Inflammation
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula…
- Trial name
- LGG (NCT01279265)
- Testing
- Nutramigen with Enflora, Nutramigen A+
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Cystic Fibrosis
Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.
- Trial name
- NCT06311292
- Testing
- Volara System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Daniel J. Weiner
Bronchopulmonary Dysplasia
Analysis of BPD in Premature Infants With Typical Imaging Changes
Bronchopulmonary dysplasia (BPD) is a common chronic respiratory disease in preterm infants. The increase in the survival rate of premature babies following the improvement of perinatal treatment and care has caused an increase…
- Trial name
- NCT04163822
- Testing
- no intervention
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Wang Jianhui
Cystic Fibrosis
Nasal Epithelial Cells/Blood Lymphocyte Markers for Cystic Fibrosis (CF)/CF Pulmonary Exacerbations
Study Hypothesis: We hypothesize that cellular markers from nasal epithelial cells and blood lymphocytes can serve as potential biomarkers reflect the underlying inflammatory state of the lung and will be helpful in determining…
- Trial name
- NCT00381628
- Testing
- epithelial cells and blood lymphocyte extraction
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Cystic Fibrosis
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and…
- Trial name
- NCT01684410
- Testing
- Alpha-1 HC 100 mg, Alpha-1 HC 200 mg
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
Cystic Fibrosis
Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis
The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of…
- Trial name
- NCT02759562
- Testing
- Andecaliximab
- Where
- 5 sites in Australia, France and 3 more
- Volunteers
- 6 people
- Sponsor
- Gilead Sciences
Hypoplastic Left Heart Syndrome, Growth Failure
Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1…
- Trial name
- NCT02657629
- Testing
- Continuous Feeding Regimen, Intermittent Bolus Feeding Regimen
- Volunteers
- 28 people
- Sponsor
- Columbia University
Induction of Labor Affected Fetus / Newborn
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
- Trial name
- NCT03348683
- Testing
- Propranolol
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Infection
Impact of Chlorhexidine Cleansing on Bacteria Colonizing the Umbilical Cord of Infants in Bangladesh
Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly.
- Trial name
- NCT00719329
- Testing
- Chlorhexidine 4.0%, Dry Cord Care
- Where
- 3 sites in United States, Bangladesh
- Volunteers
- 1,931 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Cystic Fibrosis
Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic clearance of 25(OH)D3 among participants with CF and…
- Trial name
- CF (NCT03104855)
- Testing
- d6-25-hydroxyvitamin D3
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Washington
Respiratory Syncytial Virus Infections
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns.
- Trial name
- PEPNI (NCT03614676)
- Testing
- Blood sample collection, Cord blood sample collection, Maternal Diary Card
- Where
- 40 sites in Argentina, Bangladesh and 8 more
- Volunteers
- 4,493 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Retinopathy of Prematurity
Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity
The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.
- Trial name
- BEAT-ROP (NCT00622726)
- Testing
- Bevacizumab, Conventional Laser for ROP
- Where
- 15 sites in United States
- Volunteers
- 150 people
- Sponsor
- The University of Texas Health Science Center, Houston
Cystic Fibrosis
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and…
- Trial name
- NCT03119649
- Testing
- GLPG2222 50 mg, GLPG2222 100 mg, GLPG2222 200 mg
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 59 people
- Sponsor
- Lakefront Biotherapeutics NV
Cystic Fibrosis
Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CF
This study evaluates the ability of the drug sildenafil to improved exercise capacity, cardiac performance during exercise, and quality of life in patients with moderate to severe CF lung disease.
- Trial name
- NCT02626182
- Testing
- sildenafil
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- National Jewish Health
Cystic Fibrosis
Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.
- Trial name
- NCT00625703
- Testing
- Linezolid
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of Texas Southwestern Medical Center