Clinical trials: Sepsis, Neonatal
Complication of Prematurity, Immunologic Deficiency Syndromes
Novel Mechanisms and Approaches to Treat Neonatal Sepsis
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates.
- Trial name
- NCT02554630
- Testing
- Adjuvant, Blood Collection
- Where
- United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- University of Florida
Sepsis, Pneumonia
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal…
- Conditions
- Sepsis, Pneumonia, Omphalitis, Birth Asphyxia
- Trial name
- EmONC (NCT01751945)
- Testing
- EmONC package
- Where
- Pakistan
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Sepsis
Zambia Chlorhexidine Application Trial
This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry…
- Trial name
- ZamCAT (NCT01241318)
- Testing
- Chlorhexidine gluconate (4%), Dry cord care
- Where
- Zambia
- Volunteers
- 77,535 people, healthy volunteers welcome
- Sponsor
- Boston University
Neonatal Sepsis
Use of Probiotics to Reduce Infections, Death and ESBL Colonisation
This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria.
- Trial name
- ProRIDE (NCT04172012)
- Testing
- Labinic (R) probiotic mixture
- Where
- Tanzania
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Haydom Lutheran Hospital
Prematurity, Neonatal Sepsis
Defects in Opsonophagocytosis in Premature Infants
The purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.
- Trial name
- NCT00866567
- Where
- Switzerland
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Bacteremia, Infant, Very Low Birth Weight
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants.
- Trial name
- MultilineNEO (NCT02633124)
- Testing
- Edelvaiss Multiline NEO, Standard Infusion Set
- Where
- 4 sites in France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Neonatal SEPSIS
Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital
Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.
- Trial name
- NCT03354650
- Testing
- blood culture
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Assiut University
Neonatal SEPSIS
Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
Sepsis has its greatest impact in the prematurely born (preterm) population. Neonatal sepsis (sepsis within the first month of life) causes over one million deaths worldwide annually, and is one of the most common, difficult and…
- Trial name
- NCT03291496
- Testing
- Blood Collection Preterm, Blood Collection Term, Adult Blood collection
- Where
- United States
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- University of Florida
Neonatal Sepsis
Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates
The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.
- Trial name
- NCT01479114
- Testing
- rh-GCSF
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Sepsis
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates.
- Trial name
- NCT00518596
- Testing
- Probiotic supplementation (Lactobacillus plantarum)
- Where
- 3 sites in India
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Sepsis Newborn, Infection
Glove-based Care in the NICU to Prevent Late Onset Sepsis
Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is not related to their delivery but to the hospital environment.
- Trial name
- GloveCare (NCT03078335)
- Testing
- Glove based care, Standard of Care - Hand Hygiene
- Where
- Canada
- Volunteers
- 786 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Neonatal SEPSIS
Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death
Though maternal and neonatal health are high priority areas for international development, maternal and neonatal mortality remain unacceptably high.
- Trial name
- PregnAnZI-2 (NCT03199547)
- Testing
- Azithromycin
- Where
- 2 sites in Burkina Faso, The Gambia
- Volunteers
- 11,985 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Staphylococcal Sepsis
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants.
- Trial name
- NCT00646399
- Testing
- Pagibaximab 50 mg/mL
- Where
- United States
- Volunteers
- 1,579 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Neonatal Sepsis, Markers
Tissue Doppler Echocardiographic Assessment of Cardiac Function in Neonatal Sepsis
1. To assess myocardial function in neonates with sepsis using tissue doppler echocardiography. 2. To assess sepsis induced cardiac dysfunction. 3.
- Trial name
- NCT07572916
- Testing
- cardiac troponin, and blood culture
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Assiut University
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Maternal Death, Neonatal Death
Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5.
- Conditions
- Maternal Death, Neonatal Death, Postpartum Haemorrhage, Pre-eclampsia
- Trial name
- Accelerate (NCT02468310)
- Testing
- Maternal and neonatal emergency protocols
- Where
- Ghana
- Volunteers
- 65,831 people, healthy volunteers welcome
- Sponsor
- Hannah Brown Amoakoh
Neonatal Mortality, Neonatal Sepsis
Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal
Each year four million babies die during the neonatal period, with the majority occurring in developing countries. Overall, infections account for one-third of all neonatal deaths, with proportions approaching 50% in settings…
- Trial name
- NOMS (NCT01177111)
- Testing
- Sunflower seed oil, Mustard seed oil
- Where
- Nepal
- Volunteers
- 29,260 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Neonatal Sepsis
Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe
The goal of this observational study is to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe.
- Trial name
- NeoRisk (NCT06411405)
- Testing
- Maternal medical history
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden