Clinical trials: Birth
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
The study will evaluate the safety and efficacy of gene transfer therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study.
- Trial name
- EMBARK (NCT05096221)
- Testing
- delandistrogene moxeparvovec
- Where
- 42 sites in United States, Belgium and 7 more
- Volunteers
- 126 people
- Sponsor
- Sarepta Therapeutics, Inc.
Induction of Labour
REgistry of MisOprostol 200 µg Vaginal dElivery System
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included.
- Trial name
- REMOVE (NCT02242214)
- Testing
- Misoprostol
- Where
- Netherlands
- Volunteers
- 106 people
- Sponsor
- Ferring Pharmaceuticals
Neonatal Respiratory Distress
Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS).
- Trial name
- NCT03582930
- Testing
- Infasurf Aero
- Where
- 5 sites in United States
- Sponsor
- ONY
Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst
Hot AXIOS System Japan Post Market Survey
To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.
- Conditions
- Pancreatic Pseudocyst Infection, Pancreatic Pseudocyst, Walled Off Necrosis Infection, Walled Off Necrosis
- Trial name
- NCT03797209
- Testing
- EUS-guided fistulization AXIOS
- Where
- 40 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Boston Scientific Japan K.K.
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Venous Thromboembolism
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
- Trial name
- DaPaR (NCT05536791)
- Testing
- Dabigatran Etexilate (DE)
- Where
- 6 sites in Germany, Netherlands and 2 more
- Sponsor
- Boehringer Ingelheim
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Respiratory Syncytial Virus (RSV)
Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants
To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with Kaiser Permanente Northern California (KPNC) to study the vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy…
- Trial name
- NCT07249320
- Testing
- ABRYSVO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Cytomegalovirus (CMV) Infection
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age…
- Trial name
- NCT03940586
- Testing
- Letermovir oral granules, Letermovir tablet, Letermovir intravenous
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 65 people
- Sponsor
- Merck Sharp & Dohme LLC
Functional Gastrointestinal Disorders (FGIDs), Weight Loss
Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and…
- Trial name
- NCT07320287
- Testing
- RO water, LiveSpo PREG-MOM, LiveSpo CONSY
- Where
- Vietnam
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Anabio R&D
Healthy
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
- Trial name
- NCT02158572
- Testing
- AG200-15
- Volunteers
- 2,032 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Reactive Airways Disease (RAD)
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
- Trial name
- NCT00685126
- Testing
- Levalbuterol HCl Inhalation Solution, Albuterol HCl Inhalation Solution
- Where
- 34 sites in United States, Canada
- Volunteers
- 117 people
- Sponsor
- Sumitomo Pharma America, Inc.
Infant Developmental Assessment
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or…
- Trial name
- NCT01362660
- Testing
- Unintentional exposure in utero
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Pfizer
Birth Asphyxia
Asphyxia Associated Metabolite Biomarker Investigation 2
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia.
- Trial name
- AAMBI2 (NCT04714502)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 144 people
- Sponsor
- InfanDx AG
Diabetes (Insulin-requiring, Type 1 or Type 2)
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the…
- Trial name
- NEXUS (NCT07227805)
- Testing
- NMX8, 780G
- Where
- 9 sites in Belgium, Denmark and 2 more
- Volunteers
- 116 people
- Sponsor
- Medtronic MiniMed, Inc.
Heartfailure
Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.
- Trial name
- RallyX4 (NCT02066467)
- Testing
- Left Ventricular lead implant: ACUITY X4® Lead Family
- Where
- 83 sites in Austria, Belgium and 16 more
- Volunteers
- 863 people
- Sponsor
- Boston Scientific Corporation
Rotavirus Gastroenteritis
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
- Trial name
- NCT01177657
- Testing
- Stool sampling
- Where
- Brazil
- Volunteers
- 1,944 people
- Sponsor
- GlaxoSmithKline
Infant, Small for Gestational Age
Efficacy and Safety of DA-3002 in Short Children Borns SGA.
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.
- Trial name
- SGA (NCT02770157)
- Testing
- DA-3002, Genotropin®
- Where
- South Korea
- Volunteers
- 75 people
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and…
- Trial name
- NCT03972345
- Testing
- Norditropin® FlexPro®
- Where
- Germany
- Volunteers
- 750 people
- Sponsor
- Novo Nordisk A/S