Clinical trials: Neonatal Infections
Cystic Fibrosis, Lung Disease
Benefits and Risks of Newborn Screening for Cystic Fibrosis
Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive genetic disorder of the white population, there are often delays in diagnosis and hence start of treatment.
- Conditions
- Cystic Fibrosis, Lung Disease, Pseudomonas Infections
- Trial name
- NCT00014950
- Testing
- CF newborn screening
- Where
- 2 sites in United States
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hyper-Immunoglobulin E. Syndrome (HEIS), Chronic Granulomatous Disease (CGD)
Skin Immunity Sample Collection Involving Blisters and Biopsies
Background: The way the body heals and protects itself from getting sick is called the immune response. Some people with weak immune systems get sick often or get rashes and skin infections.
- Trial name
- NCT03921515
- Testing
- Blister induction, Skin Biopsies
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Beta-Thalassemia, Hepatitis C
Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus
Patients with transfusion dependent Beta Thalassemia suffer from a high incidence of Hepatitis C infection especially in developed countries as Egypt.
- Trial name
- NCT03961828
- Testing
- Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni]
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Tanta University
COVID-19
Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery
To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.
- Trial name
- NCT05564884
- Testing
- no intervantion
- Where
- Israel
- Volunteers
- 58 people
- Sponsor
- Rabin Medical Center
Hemoglobinopathies, Sickle Cell Disease
ERN-EuroBloodNet Registry on Patients With Rare Red Blood Cell Defects and COVID-19
Patients with red blood cell disorders (RBCDs), such as Sickle cell disease (SCD) and Thalassemia, are chronic, life-threatening conditions that can become multi-organ complications over time, and are likely at an increased risk…
- Conditions
- Hemoglobinopathies, Sickle Cell Disease, Sickle Cell Anemia, Sickle Beta Thalassemia
- Trial name
- NCT06831799
- Testing
- Non applicable, is a patient registry
- Where
- Spain
- Volunteers
- 684 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
MRSA, Cystic Fibrosis
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
- Trial name
- NCT03181932
- Testing
- Vancomycin inhalation powder
- Where
- 71 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Savara Inc.
Cytomegalovirus Retinitis, HIV Infections
Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two…
- Trial name
- NCT00000665
- Testing
- Foscarnet sodium, Ganciclovir
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sepsis, Meningitis
Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial
A research trial which compares standard of care against employing a novel device for immobilization of babies undergoing upright LP, the present working name for the device is LP Comfort Seat (LPCS).
- Trial name
- NeoCALM (NCT06811428)
- Testing
- A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS), Standard of Care (SOC)
- Volunteers
- 68 people
- Sponsor
- Joel Cox
COVID-19, Cystic Fibrosis
COVID-19 Antibody Responses in Cystic Fibrosis
Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due…
- Trial name
- CAR-CF (NCT05614336)
- Testing
- Blood sample
- Where
- 19 sites in France
- Volunteers
- 331 people
- Sponsor
- Hospices Civils de Lyon
Catheter-related Bloodstream Infection, Preterm
Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
Epicutaneo-caval catheters (ECCs) are widely used in neonatal intensive care units (NICUs). They are small catheters inserted via superficial veins of the limbs or scalp using direct vein visualization The pathogenic…
- Conditions
- Catheter-related Bloodstream Infection, Preterm, Catheter Infection, Catheter Complications
- Trial name
- LOOSEN (NCT05729321)
- Testing
- neutrox
- Where
- 2 sites in Italy
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Cystic Fibrosis
Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the burden of Pseudomonas.
- Trial name
- NCT02694393
- Testing
- sodium nitrite
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Schmidhofer, Mark, MD
Vitamin D Deficiency
Comparison of Maternal and Neonatal Vitamin D Levels in Term Neonates With and Without Early Onset Sepsis
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality.
- Trial name
- NCT02019836
- Testing
- Determining maternal and neonatal vitamin D levels
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Healthy, Muscular Dystrophy
Studies of Patients With Skin Disease, Patients With Neurological Degenerations, and Normal Volunteers
It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of…
- Conditions
- Healthy, Muscular Dystrophy, Retinal Degeneration, Skin Diseases
- Trial name
- NCT00001164
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Maternal Infection Affecting Newborn
Maternal Genitourinary Infections and Adverse Perinatal Outcomes
The primary aim of this study is to determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) on preterm live birth in Sylhet district…
- Trial name
- MIST (NCT01572532)
- Testing
- Screening treatment and referral
- Where
- Bangladesh
- Volunteers
- 9,712 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Infant, Newborn, Diseases, Sepsis
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth.
- Conditions
- Infant, Newborn, Diseases, Sepsis, Puerperal Infection
- Trial name
- NCT00136370
- Testing
- Chlorhexidine, Birth canal wipe, sterile water external genital wipe
- Where
- South Africa
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Zika Virus Infection on Fetus and Child During the Pregnancy
Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America
The Zika epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due…
- Trial name
- ZIKA-DFA-BB (NCT02810210)
- Testing
- fundus examination, Head ultrasound
- Where
- 6 sites in France, French Guiana and 2 more
- Volunteers
- 1,180 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Covid19 and Pregnancy
Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment
The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of…
- Trial name
- NCT06362486
- Testing
- Severity of infection, time of infection., Mental health assessment, biological
- Where
- Spain
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.
Chikungunya Virus Infection, Neonatal
Against Chikungunya Virus and Neonatal Infection
The goal of this clinical trial is to learn if administration of plasma, from a whole blood donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum…
- Conditions
- Chikungunya Virus Infection, Neonatal, Transfusion, Encephalopathy
- Trial name
- ConvictionCHIK (NCT07190560)
- Testing
- plasma transfusion : PC-CHIK-V
- Where
- 3 sites in France, French Guiana and 1 more
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Maternal Syphilis During Pregnancy - Baby Not Yet Delivered, Congenital Syphilis
Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns
A dramatic rise in syphilis has been recently reported in the US between 2000-2017, which was followed also by a dramatic rise in congenital syphilis (CS).
- Trial name
- NCT03814096
- Testing
- Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)
- Where
- 2 sites in United States
- Sponsor
- Stanford University
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