Clinical trials: Neonatal SEPSIS
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Neonatal Staphylococcal Sepsis
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S.
- Trial name
- N002 (NCT00631878)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Biosynexus Incorporated
Rupture of Membranes Prior to Onset of Labor
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
The goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged…
- Trial name
- PROMab (NCT07563504)
- Testing
- Ampicillin, Ampicillin + gentamicin
- Where
- 3 sites in Malaysia
- Volunteers
- 320 people
- Sponsor
- Sarawak General Hospital
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serocorrelate of Protection Against GBS (PREPARE WP3)
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- NCT04732026
- Where
- 6 sites in France, Italy and 4 more
- Volunteers
- 600 people
- Sponsor
- St George's, University of London
Premature Birth, Respiratory Distress Syndrome in Premature Infant
Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns
Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid.
- Conditions
- Premature Birth, Respiratory Distress Syndrome in Premature Infant, Sepsis, Intraventricular Hemorrhage of Prematurity
- Trial name
- PhyCordPrem (NCT06280872)
- Testing
- Physiological Based Cord Clamping, Differed Cord Clamping
- Where
- 2 sites in Belgium
- Volunteers
- 180 people
- Sponsor
- Queen Fabiola Children's University Hospital
Group B Streptococcus, Sepsis
Management of Infants Born to Group B Streptococcus Positive Mothers.
Intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset neonatal sepsis caused by GBS. According to current recommendations, the evaluation of infants at risk for GBS sepsis should include a…
- Conditions
- Group B Streptococcus, Sepsis, Infant, Newborn
- Trial name
- NCT00716781
- Volunteers
- 16,394 people
- Sponsor
- IRCCS Burlo Garofolo
Sepsis of the Newborn
Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.
- Trial name
- NCT01006499
- Testing
- Pentoxifylline, pentaglobin
- Where
- Turkey (Türkiye)
- Volunteers
- 204 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Sepsis Newborn, Malaria
Immune Dysfunction in Newborn Sepsis
The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.
- Conditions
- Sepsis Newborn, Malaria, Immune Responses
- Trial name
- RECIPAL (NCT03780712)
- Testing
- Non applicable
- Volunteers
- 585 people
- Sponsor
- BioMérieux
Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant
IgM-Enriched Immunoglobulin for Neonatal Sepsis
This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS).
- Conditions
- Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant, Inflammation, Infant, Newborn, Disease
- Trial name
- NCT04041765
- Testing
- IgM-enriched IVIG
- Volunteers
- 70 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
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
Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP…
- Trial name
- NCT05022043
- Testing
- Serum Presepsin
- Where
- Egypt
- Volunteers
- 124 people
- Sponsor
- Tanta University
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Neonatal Sepsis
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and…
- Trial name
- NCT01120678
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- University of Virginia
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Sepsis Newborn
The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis.
- Trial name
- NCT06191523
- Testing
- Control Group, Treatment Group
- Where
- Indonesia
- Volunteers
- 42 people
- Sponsor
- Universitas Sebelas Maret
Neonatal Herpes Simplex Infection, Neonatal HSV Infection
Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection
This study seeks to identify and test host RNA expression profiles in context to protein biomarkers in dried blood spot samples as novel diagnostic markers of neonatal herpes simplex virus infection and to improve the…
- Conditions
- Neonatal Herpes Simplex Infection, Neonatal HSV Infection, Neonatal Infection, Newborn; Infection
- Trial name
- NCT05226949
- Where
- 2 sites in Denmark
- Volunteers
- 159 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Late-Onset Neonatal Sepsis
Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).
- Trial name
- EMERAUDE (NCT03299751)
- Testing
- Diagnostic performances of biomarkers combination
- Where
- 2 sites in France
- Volunteers
- 233 people
- Sponsor
- Hospices Civils de Lyon
Antepartum Hemorrhage, Postpartum Hemorrhage
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected.
- Conditions
- Antepartum Hemorrhage, Postpartum Hemorrhage, Anemia, Eclampsia
- Trial name
- SRC (NCT02797353)
- Testing
- Maternal Neonatal and Child Health Interventions
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Infection, Enterocolitis, Necrotizing
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide…
- Conditions
- Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
- Trial name
- NCT02116699
- Testing
- oropharyngeal mother's milk, oropharyngeal sterile water
- Where
- 5 sites in United States
- Volunteers
- 260 people
- Sponsor
- Endeavor Health
Late-onset Sepsis
Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days
- Trial name
- NCT02424734
- Testing
- Ceftaroline Fosamil, Ampicillin, Aminoglycoside
- Where
- 4 sites in United States, Hungary
- Volunteers
- 11 people
- Sponsor
- Pfizer