Clinical trials: Neonatal, open to volunteers
Surfactant, Respiratory Distress Syndrome (Neonatal)
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better.
- Trial name
- SALTI (NCT07030270)
- Testing
- Surfactant Administration through Laryngeal or Supraglottic Airway, Surfactant Administration through Thin Catheter
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
The main objective of the Phase 2 part of the trial is to assess the immunogenicity of GBS-NN/NN2 vaccine at birth in infant participants and to determine the occurrence of serious adverse events (SAEs) and adverse event of…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- MOTIVATION (NCT07922226)
- Testing
- GBS-NN/NN2 vaccine
- Volunteers
- 6,600 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Neonatal Seizure
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
This Phase 4, multicenter, single-arm, open-label study evaluates the effect of intravenous Sezaby (phenobarbital sodium) on electrocardiographic safety, including the QT interval, in neonates with seizures.
- Trial name
- NCT07923734
- Testing
- Sezaby
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Sun Pharma Advanced Research Company Limited
Intellectual Disabilities, Congenital Anomaly
Genome Medical Sequencing for Gene Discovery
Background: A number of rare inherited diseases affect only a few patients, and the genetic causes of these conditions remain unknown.
- Conditions
- Intellectual Disabilities, Congenital Anomaly, Rare Disorders
- Trial name
- NCT01087320
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Accelerating Maternal and Newborn Survival: The AMANI Study
The goal of this cluster randomized controlled trial is to learn if a practice facilitation package (including both audit and feedback and enhanced mentorship) can increase the use of maternal and perinatal death surveillance and…
- Conditions
- Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality, Neonatal Mortality, Perinatal Mortality
- Trial name
- AMANI (NCT07560839)
- Testing
- Audit and Feedback, Enhanced Mentorship
- Where
- Kenya
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Washington
Thrombocytopenia, Neonatal Alloimmune
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Trial name
- FREESIA-1 (NCT06449651)
- Testing
- Nipocalimab
- Where
- 21 sites in Belgium, Brazil and 10 more
- Volunteers
- 39 people
- Sponsor
- Janssen Research & Development, LLC
Thrombocytopenia, Neonatal Alloimmune
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Trial name
- FREESIA-3 (NCT06533098)
- Testing
- Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone
- Where
- 38 sites in United States, Austria and 9 more
- Volunteers
- 50 people
- Sponsor
- Janssen Research & Development, LLC
Midwifery Education, Neonatal Care Education
Effect of Gamified Neonatal Initial Care Education on Midwifery Students
This randomized controlled trial aims to evaluate the effectiveness of a gamified neonatal initial care educational intervention on knowledge, clinical skills, and self-efficacy among undergraduate midwifery students.
- Trial name
- NCT07910929
- Testing
- Gamified Hybrid Escape Room-Based Neonatal Initial Care Education, Conventional Theoretical Neonatal Initial Care Education
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- KTO Karatay University
Sickle Cell Disease, Sickle Cell Anaemia
Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children.
- Conditions
- Sickle Cell Disease, Sickle Cell Anaemia, Sickle Cell Anemia
- Trial name
- RESCUE (NCT07282210)
- Testing
- Senicapoc
- Where
- 4 sites in Canada
- Volunteers
- 65 people
- Sponsor
- Biossil Inc.
Oligohydramnios, Heparin
Effect of LMWH on Neonatal Outcomes in Isolated Oligohydramnios
The pregnant women who meet the study requirements will be included in the study. They will be randomly assigned to receive either the usual treatment or the usual treatment along with an additional medicine.
- Conditions
- Oligohydramnios, Heparin, Neonatal Outcomes
- Trial name
- NCT07907731
- Testing
- Enoxaparin (LMWH), Dextrose Water
- Where
- Pakistan
- Volunteers
- 106 people
- Sponsor
- PAEC General Hospital, Islamabad
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Neonatal Congenital Heart Disease
Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
This is a prospective observational screening study. First, researchers will optimize a two-indicator screening protocol for neonatal congenital heart disease (NCHD) adapted to high-altitude regions and evaluate its screening…
- Trial name
- NCT07901998
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Sepsis, PROM, Preterm (Pregnancy)
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth.
- Conditions
- Sepsis, PROM, Preterm (Pregnancy), Early-Onset Neonatal Sepsis, Preterm Premature Rupture of Membrane
- Trial name
- SAUNA (NCT06377397)
- Testing
- Antibiotics
- Where
- 9 sites in India
- Volunteers
- 1,500 people
- Sponsor
- Indian Council of Medical Research
Digital Health, Maternal Health Services
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
DED 2.0 is a stepped-wedge cluster-randomized trial testing whether an integrated digital health ecosystem (KuApps, a service-monitoring dashboard, AI-assisted OCR for handwritten records, two-way WhatsApp-based health…
- Conditions
- Digital Health, Maternal Health Services, Prenatal Care, Intensive Care, Neonatal
- Trial name
- DED (NCT07842224)
- Testing
- Digitally Enabled District (DED)
- Where
- Indonesia
- Volunteers
- 10,800 people, healthy volunteers welcome
- Sponsor
- Summit Institute for Development, Indonesia
Neonatal Respiratory Distress Related Conditions, Meconium
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth.
- Conditions
- Neonatal Respiratory Distress Related Conditions, Meconium, Perinatal Morbidity, Neonatal Acidosis
- Trial name
- PEARL (NCT07274527)
- Testing
- Intrauterine pressure catheter, Standard obstetric care at discretion of delivery provider
- Where
- United States
- Volunteers
- 320 people
- Sponsor
- Medical College of Wisconsin
Homozygous Familial Hypercholesterolemia
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
This study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to <18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and…
- Trial name
- SPRUCE (NCT07473843)
- Testing
- Zodasiran
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 10 people
- Sponsor
- Arrowhead Pharmaceuticals
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the…
- Conditions
- Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion, Neonatal Brain Injury
- Trial name
- AMNIO-BRAIN (NCT07610642)
- Testing
- Intrauterine Pressure Catheter, Standard obstetric care at discretion of delivery provider
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medical College of Wisconsin
Heterozygous Familial Hypercholesterolemia (HeFH)
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
A phase 1/2, two-part trial consisting of an open label dose-escalation part and a randomized, double blind, placebo-controlled part to investigate safety, tolerability, pharmacokinetics, and efficacy with EDIT-401 gene editing…
- Trial name
- NCT07894887
- Testing
- Drug: EDIT-401
- Where
- 2 sites in Australia
- Volunteers
- 56 people
- Sponsor
- Editas Medicine, Inc.
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
The Correlation Between Red Cell Transfusion and Complications of Prematurity
The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity.
- Conditions
- Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD), Enterocolitis, Necrotizing, Intraventricular Hemorrhage Neonatal
- Trial name
- NCT07123948
- Testing
- Wechsler Intelligence Test, performed by educated psychologists
- Where
- Croatia
- Volunteers
- 128 people
- Sponsor
- Clinical Hospital Center Rijeka
Neonatal Sepsis, Neutropenia
G-CSF In Neonatal Sepsis With Neutropenia
This study will evaluate whether adding G-CSF to standard treatment improves outcomes in newborns (0-28 days) with sepsis and neutropenia.
- Trial name
- NCT07888829
- Testing
- Granulocyte-colony stimulating factor (G-CSF), Standard Sepsis Management
- Where
- Pakistan
- Volunteers
- 52 people
- Sponsor
- University of Health Sciences Lahore