Clinical trials: Newborn Infant
Infants, Newborn
Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code…
- Trial name
- NCT04218929
- Testing
- Study Formula (SF), Comparator Formula (CF)
- Where
- 27 sites in United States
- Volunteers
- 311 people, healthy volunteers welcome
- Sponsor
- ByHeart
Irritable Bowel Syndrome, Wheat Sensitivity
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
- Trial name
- Wheat-IBS (NCT02572908)
- Testing
- Sourdough wheat bread, Regular yeast baked toast bread, Gluten-free diet
- Where
- Finland
- Volunteers
- 26 people
- Sponsor
- Oy Karl Fazer Ab
Infantile Colic
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
- Trial name
- Coco (NCT01721850)
- Testing
- control formula, intervention formula 1, intervention formula 2
- Where
- 18 sites in Germany, Italy
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Prematurity, Premature Birth
Vibroacoustic Study of Lung Development in Newborn Infants
Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes.
- Conditions
- Prematurity, Premature Birth, Premature Lungs, Prematurity; Extreme
- Trial name
- NCT05827250
- Testing
- imPulse Tor
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Level 42 AI, Inc.
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.
- Trial name
- NCT00787917
- Testing
- Omalizumab, Itraconazole
- Where
- 10 sites in Belgium, Germany and 3 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
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.
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF)
Study With Phage for CF Subjects With Pseudomonas Lung Infection
The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects.
- Trial name
- NCT06998043
- Testing
- BX004
- Where
- 14 sites in United States
- Volunteers
- 63 people
- Sponsor
- BiomX Ltd
Atopic Dermatitis (AD)
EFFICACY AND TOLERANCE OF AN EMOLLIENT CREAM IN SKIN OF COLOR
The aim of this study is to evaluate the efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under…
- Trial name
- NCT07839897
- Testing
- Emollient cream RV4660B
- Where
- Brazil
- Volunteers
- 59 people
- Sponsor
- Pierre Fabre Dermo Cosmetique
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Cystic Fibrosis
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.
- Trial name
- NCT05504837
- Testing
- KB407 (Nebulization)
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Krystal Biotech, Inc.
Labour Onset and Length Abnormalities, Labor; Forced or Induced, Affecting Fetus or Newborn
Dilapan-S/Dilasoft E-Registry in Induction of Labor
International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.
- Trial name
- DSREGISTRYIL (NCT02318173)
- Testing
- Dilapan-S
- Where
- 11 sites in United States, Czechia and 5 more
- Volunteers
- 444 people
- Sponsor
- Medicem International CR s.r.o.
Cystic Fibrosis
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00503490
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Amgen
Cystic Fibrosis
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene.
- Trial name
- NCT01288170
- Testing
- Nebcinal Tobi, Tobi Nebcinal
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- Erempharma
Cystic Fibrosis
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein.
- Trial name
- NCT00970346
- Testing
- OligoG CF-5/20
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- AlgiPharma AS
Cystic Fibrosis
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).
- Trial name
- NCT00130182
- Testing
- denufosol tetrasodium (INS37217)
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator…
- Trial name
- NCT05331183
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 81 sites in Austria, Belgium and 13 more
- Volunteers
- 297 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Gastroesophageal Reflux
A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.
- Trial name
- NCT00855361
- Testing
- Rabeprazole sodium
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 69 people
- Sponsor
- Janssen Research & Development, LLC
Cystic Fibrosis, Bronchiectasis
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of…
- Trial name
- NCT03534986
- Testing
- International Biophysics AffloVest, Hill-Rom The Vest, Respirtech inCourage
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- International Biophysics Corporation