Clinical Trials Logo

Clinical Trial Summary

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). In addition to the intervention, standard regimen antibiotics are also given within 1 hour. The IVIG is given for 3 days and primary and secondary outcomes will be collected. Risk factors are both from maternal and neonate origin.


Clinical Trial Description

This randomized-controlled trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia aims to determine the efficacy of prophylactic IgM-Enriched IVIG in preventing EONS. A total of 70 very low birth weight (VLBW) neonates with risk factors for EONS including maternal factors of premature rupture of membrane (PROM), fever, urinary tract infection (UTI), chorioamnionitis, and neonatal factor of prematurity and resuscitation history will be collected. These neonates within 1 hour of life will then be administered either placebo or IgM-enriched IVIG 0.25g/kg/day for 3 days, in addition to first-line empiric antibiotic. Randomization is done using simple randomization. Triple masking (Participant, Investigator, Outcomes Assessor) is conducted.

These neonates will then be clinically observed and evaluated for early mortality (mortality below 7 days), hemodynamics, length of stay, blood culture results, C-Reactive Protein (CRP), IT ratio, routine hematological examination, and IgGAME as parameters of improvement and prevention of EONS.

STATA version 12 (Macintosh version) will be used for data management and statistical analyses. The variables will first be presented descriptively, continued with bivariate and multivariate analysis. Bivariate analysis will be conducted between independent and dependent variables using chi-square/Fisher's exact test, Student's t-test, and Kruskal-Wallis. Variables with p-values <0.25 will be included in the multivariate analysis using logistic regression. The investigators will use two-sided p-values in our analysis with a p < 0.05 level of significance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04041765
Study type Interventional
Source Fakultas Kedokteran Universitas Indonesia
Contact Rinawati Rohsiswatmo, MD, PhD
Phone +62811133094
Email rinarohsis@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date September 2019
Completion date August 2020

See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect