Clinical trials: Neonatal Sepsis
Group B Streptococcus Neonatal Sepsis
Rapid Detection of Group B Strep- 35-37 Week Study
The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep growing in the vagina and rectum can be performed with similar success to the routine culture.
- Trial name
- NCT00331019
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Michigan
Sepsis
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB…
- Trial name
- PROABIS (NCT03730636)
- Testing
- PCT dosage
- Where
- France
- Volunteers
- 511 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Candidiasis
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
- Trial name
- MAGIC-2 (NCT00815516)
- Testing
- micafungin, amphotericin B deoxycholate
- Where
- 17 sites in United States, Brazil and 10 more
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Birth Asphyxia, Very Low Birth Weight Baby
Naushero Feroze Neonatal Survival Project
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan.
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Trial name
- AKU (NCT01350765)
- Testing
- Intervention, Control
- Where
- Pakistan
- Volunteers
- 37,201 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Sepsis
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study.
- Trial name
- NCT01362504
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Herpes Simplex Virus, Neonatal Sepsis
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies. Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been adequately studied in full-term or premature neonates.
- Trial name
- NCT00942084
- Testing
- Acyclovir
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Phillip Brian Smith
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
COVID, SARS-CoV-2
European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide.
- Conditions
- COVID, SARS-CoV-2, ARDS, Human, Refractory Hypoxemia
- Trial name
- EuroECMO-COVID (NCT04366921)
- Where
- 97 sites in Austria, Belgium and 17 more
- Volunteers
- 150 people
- Sponsor
- Maastricht University Medical Center
Neonatal Sepsis, Shock, Septic
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure…
- Trial name
- NCT06306001
- Testing
- Methylene Blue
- Where
- India
- Volunteers
- 130 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Sepsis, Congenital Diaphragmatic Hernia
Inflammatory Cytokine Quantification in Infants
This study proposes to quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure…
- Conditions
- Sepsis, Congenital Diaphragmatic Hernia, Neonatal Cardiopulmonary Failure
- Trial name
- NCT01155830
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- University of Utah
Infant, Newborn, Infant, Low Birth Weight
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- IVIG (NCT01203345)
- Testing
- IVIG
- Where
- 8 sites in United States
- Volunteers
- 2,416 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Late Onset Neonatal Sepsis
Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis
Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin…
- Trial name
- BVPIMNBLOS (NCT02503761)
- Testing
- Meropenem.
- Volunteers
- 100 people
- Sponsor
- Mansoura University
Infant, Newborn, Neonatal SEPSIS
7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis
The optimum duration of intravenous antibiotic therapy for culture-proven neonatal bacterial sepsis is not known. Current practices, ranging from 7 days to 14 days of antibiotics, are not evidence-based.
- Conditions
- Infant, Newborn, Neonatal SEPSIS, Anti-bacterial Agents, Recurrence
- Trial name
- NCT03280147
- Testing
- 7-day course of antibiotics, 14-day course of antibiotics
- Where
- 7 sites in India
- Volunteers
- 261 people
- Sponsor
- Indian Council of Medical Research
Late-Onset Neonatal Sepsis
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no…
- Trial name
- NCT04842786
- Testing
- Coconut oil
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Late Onset Neonatal Sepsis
Lactoferrin for Prevention of Sepsis in Infants
The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections…
- Trial name
- NEOLACTO (NCT01525316)
- Testing
- Bovine Lactoferrin, Maltodextrin
- Where
- 3 sites in Peru
- Volunteers
- 414 people
- Sponsor
- Universidad Peruana Cayetano Heredia
Sepsis
Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis
We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature infants <2500 gm in 5…
- Trial name
- NEOLACTO (NCT01264536)
- Testing
- lactoferrin, Maltodextrin
- Where
- 3 sites in Peru
- Volunteers
- 190 people
- Sponsor
- Universidad Peruana Cayetano Heredia
Sepsis, Newborn Sepsis
T6A Biomarker for Detection of Bacterial Infection in Newborn Infants
This bi-center study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.
- Conditions
- Sepsis, Newborn Sepsis, Biomarker Discovery
- Trial name
- T6ASepsis (NCT07670624)
- Where
- 2 sites in Austria, Poland
- Volunteers
- 210 people
- Sponsor
- Salzburger Landeskliniken
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica