Clinical trials: Neonatal Infection
Sepsis, Neonatal Mortality
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care…
- Conditions
- Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections
- Trial name
- CLEAN (NCT06824350)
- Testing
- chlorination for water disinfection and surface disinfection, infection prevention and control messaging
- Where
- 2 sites in United States, Kenya
- Volunteers
- 45,450 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Staphylococcus Aureus, Microbial Colonization
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.
- Conditions
- Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
- Trial name
- NCT06283355
- Testing
- Nasal Microbiota Transplant (NMT)
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- NCT06592586
- Testing
- GBS-NN/NN2 vaccine
- Where
- 6 sites in Denmark, South Africa
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Congenital Cytomegalovirus, Cytomegalovirus Infections
Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection
This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the…
- Conditions
- Congenital Cytomegalovirus, Cytomegalovirus Infections, Neonatal Infection, Sensorineural Hearing Loss
- Trial name
- NCT07635368
- Where
- 2 sites in Denmark
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Staphylococcus Aureus, Microbial Colonization
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.
- Conditions
- Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
- Trial name
- ParentsTREAT (NCT05695196)
- Testing
- nasal microbiota transplant (NMT)
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Corona Virus Infection, Pregnancy Related
Understanding COVID-19 Infection in Pregnant Women and Their Babies
This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.
- Conditions
- Corona Virus Infection, Pregnancy Related, Neonatal Infection, Breastfeeding
- Trial name
- periCOVID (NCT04703270)
- Where
- United Kingdom
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Covid19, Pregnancy Related
Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19
Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care.
- Conditions
- Covid19, Pregnancy Related, Maternal Complication of Pregnancy, Coronavirus
- Trial name
- STOPCOVID19 (NCT04718220)
- Testing
- Antibody testing for SARS-CoV-2 IgG, Testing for SARS-CoV-2 RNA, Testing for SARS-CoV-2 IgM/IgG
- Where
- United States
- Volunteers
- 448 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Chlamydia Trachomatis Infection, Neonatal Infection
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on…
- Conditions
- Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth, Gonorrhea
- Trial name
- NCT04955717
- Testing
- Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period.
- 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
- ProGreSs (NCT04549220)
- Where
- Uganda
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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
Sars-CoV2, Covid-19
COPE - COVID-19 in Pregnancy and Early Childhood
Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for…
- Conditions
- Sars-CoV2, Covid-19, Pregnancy Complications, Pregnancy Preterm
- Trial name
- COPE (NCT04433364)
- Testing
- biological samples, questionnaires and interviews
- Where
- 27 sites in Sweden
- Volunteers
- 3,834 people, healthy volunteers welcome
- Sponsor
- Sahlgrenska University Hospital
Prenatal Infection, Congenital Infection
Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)
To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the…
- Conditions
- Prenatal Infection, Congenital Infection, Neonatal Disease
- Trial name
- CYMEVIE (NCT04822142)
- Where
- Vietnam
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Hanoi Obstetrics and Gynecology Hospital
Umbilical Cord Infection, Umbilical Sepsis
Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.
- Conditions
- Umbilical Cord Infection, Umbilical Sepsis, Neonatal Sepsis
- Trial name
- NCT05569551
- Testing
- Adhesive pouch
- Where
- Malaysia
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- AIMST University Malaysia
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations…
- 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
- PREPARE (NCT04653948)
- Where
- Uganda
- Volunteers
- 3,423 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Neonatal Sepsis, Sepsis
Probiotics for Prevention Neonatal Infection
Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world.
- Conditions
- Neonatal Sepsis, Sepsis, Neonatal Infections
- Trial name
- NCT01214473
- Testing
- Synbiotics, Maltodextrin
- Where
- 2 sites in India
- Volunteers
- 4,556 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
HIV Infections, Neonatal Infection
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal…
- Conditions
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection, Immune Tolerance
- Trial name
- IMMUNEO (NCT03383211)
- Testing
- RNAseq
- Where
- 2 sites in Moldova
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- George Washington University
Healthcare Associated Infection, Hand Hygiene
Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Infections in NICU
The purpose of this study is to determine if use of the video camera surveillance system for HH observation and performance feedback about HH compliance rates can improve the HH compliance of HCWs and reduce healthcare-associated…
- Conditions
- Healthcare Associated Infection, Hand Hygiene, Neonatal Infection
- Trial name
- CaM-HAI (NCT04053257)
- Testing
- Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
- Where
- Turkey (Türkiye)
- Volunteers
- 8,335 people, healthy volunteers welcome
- Sponsor
- Marmara University
Covid19, Vertical Transmission of Infectious Disease
Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.
- Conditions
- Covid19, Vertical Transmission of Infectious Disease, Neonatal Infection, Pregnancy Related
- Trial name
- NCT04883801
- Testing
- Reviewed clinical records and laboratory results
- Where
- Turkey (Türkiye)
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Pre-Term, Neonatal Infection
Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Non-invasively neonatal cardiac output can be measured by multiple methods, but the gold standard still remains conventional echocardiography. It is accurate, but needs a long training for new users to assess cardiac function.
- Trial name
- NInHeDyNeo (NCT04200807)
- Testing
- Ultrasound Cardiac Output Monitor (USCOM 1A)
- Where
- Lithuania
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Vilnius University
Vaginal Infection, Pregnancy Complications
Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy
In the present study, the investigators aim to evaluate the potential of oral probiotics, containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group B Streptococcus (GBS) during pregnancy.
- Conditions
- Vaginal Infection, Pregnancy Complications, Neonatal Sepsis, GBS
- Trial name
- NCT03008421
- Testing
- Astarte® (HSO Health Care GmbH, Vienna, Austria)
- Where
- Austria
- Volunteers
- 1,058 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna