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Neonatal Sepsis clinical trials

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NCT ID: NCT03078335 Completed - Infection Clinical Trials

Glove-based Care in the NICU to Prevent Late Onset Sepsis

GloveCare
Start date: June 5, 2017
Phase: N/A
Study type: Interventional

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. Preventing these infections results in shorter hospital stays for babies, less risk of long term health problems and less health care resources required to care for them. Hand washing alone doesn't remove all bacteria from the hands of healthcare workers, and studies have shown that infections in adults and children admitted to hospital decrease if health care providers use clean, non- sterile gloves when treating patients. The main focus of this study will be to find out if using gloves when caring for newborns in the NICU is better than washing hands alone. McMaster Children's Hospital and The Hospital for Sick Children will be the pilot sites to participate in a future larger study where some infants will be cared for using non-sterile gloves, and others will be cared for using the standard hand washing method.

NCT ID: NCT03008421 Completed - Clinical trials for Pregnancy Complications

Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

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. This could help to prevent neonatal morbidity and mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as early-onset or late-onset GBS infection.

NCT ID: NCT02959229 Completed - Neonatal Sepsis Clinical Trials

Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Start date: August 2014
Phase: Phase 4
Study type: Interventional

The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.

NCT ID: NCT02954926 Completed - Neonatal Sepsis Clinical Trials

Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Start date: November 2015
Phase: Phase 3
Study type: Interventional

Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.

NCT ID: NCT02797353 Completed - Anemia Clinical Trials

Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan

SRC
Start date: January 2013
Phase: N/A
Study type: Interventional

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. Aga Khan University Pakistan is intending to implement a service delivery project for the improvement of Maternal Neonatal and Child health situation through evidence based MNCH interventions.

NCT ID: NCT02702297 Completed - Clinical trials for Preterm Premature Rupture of Membranes

Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes

MuMFI-PPROM
Start date: January 7, 2016
Phase:
Study type: Observational

The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.

NCT ID: NCT02554630 Completed - Clinical trials for Immunologic Deficiency Syndromes

Novel Mechanisms and Approaches to Treat Neonatal Sepsis

Start date: February 2016
Phase:
Study type: Observational

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. The estimated cost of caring for these patients is approximately $700 million in the US alone. In an effort to help mature the neonatal immune system, several adjuvant therapies have been studied; however, none have been implemented in clinical practice. One of the most frequently considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and inflammation. Early adjuvant administration in VLBW infants may be a viable approach to reducing the incidence of early and late sepsis. This research study will characterize immune genomic expression and functional capacity at the time of birth in both term and preterm neonates and determine what effects, if any, that adjuvants have on this function. Additionally, this study will seek to determine if immune function correlates with certain microbiota.

NCT ID: NCT02503761 Completed - Clinical trials for Late Onset Neonatal Sepsis

Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis

BVPIMNBLOS
Start date: August 2013
Phase: Phase 3
Study type: Interventional

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 and gentamicin and require introduction of new agents with a wider spectrum of activity. Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy. Severe neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the NICU. Few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be available in the near future.

NCT ID: NCT02486783 Completed - Neonatal Sepsis Clinical Trials

Infection, Sepsis and Meningitis in Surinamese Neonates

InSepSur
Start date: May 2015
Phase: N/A
Study type: Observational

Suriname is a small developing country in South America with a population of half a million people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any case about 40 newborns that die each year of infection are a huge loss, also considering the small Surinamese community. Despite this overall idea on the impact of infectious disease in Surinamese neonates exact information regarding incidence, type of infection (e.g., localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes, morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g., gestational age, sex, ethnicity) are lacking. From a clinical perspective, there is still a challenge to identify neonates with infection. Neonates are often admitted with ambivalent clinical symptoms and receive preventive antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is relatively rare (0.5-3% in the United States). This complicates decisions on duration of antibiotic treatment and hospitalization significantly, while no other biomarkers exist. The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and sepsis. During infection they accumulate in the bloodstream as a result of shedding, which represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal, pediatric and adult sepsis. The shedding process reflects a critical and active process in orchestrating interaction between leukocytes and the endothelium for an effective host response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs and their sheddases are subject to change during infection and sepsis. Additionally, compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and pediatric meningitis. To date, some evidence exists of changes in levels of cAMs during malaria (in children from Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those levels have never been assessed simultaneously with levels of their sheddases in blood or CSF as a diagnostic tool. We propose that this combined approach may provide more detailed information about the extent of inflammatory activation in neonates.While a balance in levels is maintained under resting conditions or mild (local) infection, it may be perturbed during sepsis or meningitis . Thus, simultaneous measurement of these levels could promote early identification of infection, and may even distinguish between mild infection, systemic infection or meningitis. Currently, manufacturers are rapidly developing Luminex® technology as an advanced, fast, high-throughput and clinically feasible bedside tool for such an approach. We hypothesize that incidence rates of neonates with infection in Suriname are high. We further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of infection to establish incidence rates of infection, and 2) investigate diagnostic potential of our proposed biomarker combination in these neonates for infection, type of infection (e.g., local (mild), sepsis or meningitis) and outcomes.

NCT ID: NCT02473796 Completed - Malaria Clinical Trials

Home Based Child Care to Reduce Mortality and Malnutrition in Tribal Children of Melghat, India: CRCT

HBCC
Start date: January 2004
Phase: N/A
Study type: Interventional

Melghat is poorly developed tribal area in India with very high child mortality & malnutrition prevalence (grossly inadequate medical facilities). Important health problems. Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W. babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region. Melghat. Need of project : Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India. Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing government ICDS and health system. Melghat. Need of project : Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India. Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages.