Clinical trials: Newborn Infant
Small for Gestational Age Infant, Fetal Growth Restriction
Developing and Testing AI Models for Fetal Biometry and Amniotic Volume Assessment in Fetal Ultrasound Scans.
Routine fetal ultrasound scan during the second trimester of the pregnancy is a low-cost, noninvasive screening modality that has been proven to lower fetal mortality by up to 20%.
- Conditions
- Small for Gestational Age Infant, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios
- Trial name
- NCT05059093
- Testing
- Classification and segmentation deep learning models
- Where
- 6 sites in Morocco
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Deepecho
Cystic Fibrosis
Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe dose.
- Trial name
- NCT00671736
- Testing
- Moli1901
- Where
- Austria
- Volunteers
- 160 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
Cystic Fibrosis
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the…
- Trial name
- NCT02508207
- Testing
- Tezacaftor/Ivacaftor, Ivacaftor
- Where
- 7 sites in United States
- Volunteers
- 34 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Diaper Rash
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.
- Trial name
- NCT00702507
- Testing
- 0.25 % Miconazole Nitrate Ointment
- Where
- 8 sites in United States, Dominican Republic and 2 more
- Volunteers
- 200 people
- Sponsor
- Stiefel, a GSK Company
Pulmonary Infections, Pseudomonas Aeruginosa
Second Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were…
- Trial name
- NCT01069705
- Testing
- Tobramycin inhalation powder
- Where
- 17 sites in Bulgaria, Estonia and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis, Pediatric ALL
TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research…
- Trial name
- TRAM (NCT06578351)
- Where
- Singapore
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Cystic Fibrosis
Miglustat / OGT 918 in the Treatment of Cystic Fibrosis
Cystic fibrosis is a genetic disease caused by mutation of the cystic fibrosis transmembrane conductance regulator (CFTR). The purpose of the study is to investigate the effects of miglustat on CFTR function in cystic fibrosis…
- Trial name
- NCT00537602
- Testing
- miglustat
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- Actelion
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Benign Breast Disease
REGENERA Implant in Excised Non-Malignant Breast Lesions
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom…
- Trial name
- NCT04131972
- Testing
- REGENERA
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Tensive SRL
Mucopolysaccharidosis II
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous…
- Trial name
- NCT06075537
- Testing
- tividenofusp alfa
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 99 people
- Sponsor
- Denali Therapeutics Inc.
Cystic Fibrosis
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype…
- Trial name
- NCT05668741
- Testing
- VX-522 mRNA therapy, IVA
- Where
- 26 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy, Cystic Fibrosis
Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics
The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.
- Trial name
- NCT01537666
- Testing
- AeroVanc, IV vancomycin hydrochloride
- Where
- 2 sites in Australia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Savara Inc.
Sjögren-Larsson Syndrome
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of topically-applied NS2 dermatologic cream administered…
- Trial name
- NCT02402309
- Testing
- Active topical NS2 1% dermatologic cream
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Aldeyra Therapeutics, Inc.
Exocrine Pancreatic Insufficiency: Cystic Fibrosis
Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.
- Trial name
- NCT01641393
- Testing
- EUR-1008 25,000 Units, Kreon 25,000 Units
- Where
- 37 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 96 people
- Sponsor
- Forest Laboratories
Apnea, Bradycardia
microEEG for Neonatal Apnea, Bradycardia and Desaturation
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Trial name
- NCT02436616
- Testing
- microEEG
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Bio-Signal Group Corp.
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Autosomal Recessive Polycystic Kidney (ARPKD)
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
- Trial name
- NCT04782258
- Testing
- Tolvaptan Suspension, Tolvaptan Tablets
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 20 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adrenal Insufficiency
Treatment of Adrenal Insufficiency in Children
The study will be conducted in a total of 24 subjects before their 6th birthday, requiring replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or hypopituitarism.
- Trial name
- NCT02720952
- Testing
- Infacort®
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Neurocrine UK Limited
Cystic Fibrosis, Bronchiectasis
Effect of HFCWO 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
- NCT03628456
- Testing
- International Biophysics AffloVest, Hill-Rom Monarch
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- International Biophysics Corporation
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.