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Neonatal Sepsis clinical trials

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NCT ID: NCT06191523 Completed - Sepsis Newborn Clinical Trials

The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis

Start date: April 27, 2023
Phase: N/A
Study type: Interventional

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. The main question aim to answer : • Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis? The participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo. The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC and increase of sepsis score

NCT ID: NCT06002295 Completed - Neonatal Sepsis Clinical Trials

A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns

Start date: September 12, 2020
Phase: Phase 2
Study type: Interventional

Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection. Topical treatment can help to reduce the chances of infection as well as increase the chances of early removal. In this regard methylated spirit and chlorhexidine are found to be effective. Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit in newborns for prevention of omphalitis and neonatal sepsis. Materials and Methods: This randomized control trial was carried out in neonatal unit of Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated spirit was used. Neonates were followed till 10th day of life. Careful examination was done for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.

NCT ID: NCT05969327 Completed - Clinical trials for Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis

Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)

Start date: August 14, 2018
Phase: Phase 3
Study type: Interventional

Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired vertically from the mother and manifests shortly after birth. The objective of this study is to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.

NCT ID: NCT05569551 Completed - Neonatal Sepsis Clinical Trials

Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)

Start date: November 15, 2022
Phase: N/A
Study type: Interventional

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. Methods: This is a prospective double-blinded randomized controlled trial on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers were taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver and evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump.

NCT ID: NCT05416918 Completed - Neonatal Sepsis Clinical Trials

Clinical Value of Metagenomic Sequencing in Neonatal Sepsis

Start date: April 1, 2022
Phase:
Study type: Observational

This study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed sepsis. These patients will undergo both conventional methods and metagenomics sequencing to detect the pathogenic microorganisms of sepsis. The purpose of this study was to assess the clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.

NCT ID: NCT05226949 Completed - Neonatal Sepsis Clinical Trials

Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection

Start date: January 1, 2022
Phase:
Study type: Observational

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 understanding of the pathogenesis of the disease.

NCT ID: NCT05022043 Completed - Neonatal Sepsis Clinical Trials

Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

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, procalcitonin (PCT), and tumor necrosis factor-α (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis manifestations but had negative BC and No EOS included neonates free of evident clinical sepsis manifestations, had negative BC and showed no deterioration till 72-hr after admission.

NCT ID: NCT04867135 Completed - Clinical trials for Neonatal Sepsis, Late-Onset

Population Pharmacokinetics of Amikacin in Neonates

Start date: December 1, 2019
Phase:
Study type: Observational

Aminoglycosides such as Amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli. Despite the frequency of this indication, it has not yet been possible to establish definitive dosage schedules that ensure effectiveness and low risk of toxicity, due to the high pharmacokinetic variability observed in this population. In addition to anthropometric variables, evidence from retrospective studies suggests that sepsis could be capable of significantly modifying the pharmacokinetics of aminoglycosides in neonates, but the investigators suggest conducting prospective studies of higher methodological quality to verify this hypothesis. Due to the lack of pharmacokinetic and pharmacodynamic (PK / PD) studies of Amikacin in this group of patients, the investigators have raised the need to develop a prospective observational study; describing a PK / PD model of amikacin in newborns with suspected sepsis.

NCT ID: NCT04792918 Completed - Clinical trials for Late-Onset Neonatal Sepsis

Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

NEC
Start date: February 11, 2021
Phase:
Study type: Observational [Patient Registry]

Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.

NCT ID: NCT04513691 Completed - Clinical trials for Early-Onset Sepses, Neonatal

A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator

Start date: September 30, 2020
Phase:
Study type: Observational

This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University Medical Center Phoenix. Newborns enrolled will be at least 35 weeks gestational age (GA) and have a maternal diagnosis of at least suspected or confirmed CAM. The data will include those newborns whose assessment and treatment were not guided by the EOS calculator which was implemented on August 28, 2019 and those with which the EOS calculator was utilized. A secondary objective is to show the economic impact with utilization of the EOS calculator. Data collected will include full laboratory workups including complete blood counts (CBC), blood cultures, antibiotic usage, length of time in the newborn nursery and total length of stay.