Clinical trials: Neonatal Infections
Neonatal Sepsis
The Volume of Blood Submitted for Culture in Neonates - a Multicentre Quality Improvement Initiative.
The study will examine if introducing the practice of checking the volume of blood culture samples in neonates by bedside weighing will improve the sensitivity of the test and increase confidence in negative results affecting the…
- Trial name
- VOB4C (NCT04455022)
- Testing
- Bedside blood culture bottles weighing combined with educational interventions.
- Where
- 4 sites in Poland
- Volunteers
- 600 people
- Sponsor
- Medical University of Warsaw
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Neonatal Sepsis
Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis
The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic…
- Trial name
- suPAR (NCT01294865)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ankara University
Tuberculosis
Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas…
- Trial name
- NCT01479972
- Testing
- VPM1002, BCG
- Where
- South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Group B Streptococci, Respiratory Distress in Newborn
Streptococcal Infection and Respiratory Distress in Newborns
This study will evaluate whether babies are more at risk of developing breathing problems if their mothers carry group B streptococci (GBS) in vagina/rectum, and whether the breathing problem is due to phospholipids released by…
- Trial name
- NCT00612937
- Where
- 2 sites in United States
- Volunteers
- 13,180 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cytomegalovirus Retinitis, HIV Infections
A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e.
- Trial name
- NCT00001999
- Testing
- Globulin, Immune, Ganciclovir
- Where
- United States
- Sponsor
- American National Red Cross
Hepatitis C Virus Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4…
- Trial name
- NCT02301936
- Testing
- LDV/SOF
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Gilead Sciences
Acute Bacterial Infections, Acute Viral Infections
300 Antibody Diagnostic Test Kit
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections.
- Trial name
- Antibody 300 (NCT01646411)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The Plasma Source
Bronchiolitis, Pneumonia
A Study of Tobacco Smoke and Children With Respiratory Illnesses
This study aims to assess the feasibility of using an intervention for environmental smoke exposure in children that uses cotinine testing results with written materials and telephone counseling for a potential future study of…
- Conditions
- Bronchiolitis, Pneumonia, Reactive Airway Disease, Asthma
- Trial name
- NCT03062709
- Testing
- Breathe Easy Coalition written materials, Maine Tobacco Helpline, Urine cotinine testing
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MaineHealth
Pre-Exposure Prophylaxis, Hiv
Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)
The aim of this study is to examine the effect of social media intervention on the use of pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New Haven area.
- Conditions
- Pre-Exposure Prophylaxis, Hiv, Men
- Trial name
- NCT04417946
- Testing
- PrEP messages, Heath messages
- Where
- 2 sites in United States
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- Yale University
Neonatal Hypocalcemia, Neonatal Sepsis
Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system.
- Trial name
- NCT02147327
- Volunteers
- 120 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Microbial Colonization, Preterm Birth
Gastric Bacterial Colonization of Preterm Neonates
This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU.
- Trial name
- NCT05385939
- Testing
- Observational
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Cystic Fibrosis
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic…
- Trial name
- AZLI CAT (NCT01641822)
- Testing
- AZLI, Tobramycin inhalation solution
- Where
- 71 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Tuberculosis
PPD Size and Mycobacteria Tuberculosis ELISPOT in Children Who Have Received BCG in Neonate Period
To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period.
- Trial name
- NCT00172783
- Where
- Taiwan
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Prematurity, Microbial Colonization
Microbiome Establishment in Preterm Infants
Our bodies are home to millions and millions of microbes (bacteria, fungi and viruses), that live in harmony with us without producing any negative (disease producing) effects.
- Trial name
- PIMENTO (NCT05803577)
- Where
- Ireland
- Volunteers
- 91 people
- Sponsor
- University College Cork
Tuberculosis
HRZE Fasted/Fed in Newly Diagnosed TB
WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug concentrations are too low; on the other hand: if this is not tolerated, drugs could also be taken with food.
- Trial name
- FASTFOOD (NCT02121314)
- Testing
- intravenous administration of 1st line TB drugs, day 1
- Where
- Indonesia
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
HIV Infections, Circumcision
Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in sub-Saharan Africa. Although adult male circumcision (MC) has been shown to reduce the heterosexual acquisition of HIV by men by about…
- Trial name
- NCT00971958
- Testing
- Circumcision, Mogen Clamp, Plastibell
- Where
- Botswana
- Volunteers
- 1,235 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Colitis, HIV Infections
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these…
- Trial name
- NCT00000768
- Testing
- Glutamic acid hydrochloride, Ganciclovir
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus Retinitis, HIV Infections
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral ganciclovir during a 28-day dosing period.
- Trial name
- NCT00000668
- Testing
- Ganciclovir
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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