EFFECT OF INTRAVENOUS IMMUNOGLOBULIN IN PREVENTION OF PRETERM NEONATAL SEPSIS: A CLINICAL TRIAL STUDY
Journal Title: Acta HealthMedica - Year 2017, Vol 2, Issue 3
Abstract
Background: The incidence of severe sepsis and septic shock is higher among preterm infants. Prevention of neonatal sepsis has remained a global challenge in recent decades. The role of intravenous immunoglobulin (IVIG) as an adjunctive treatment in sepsis has been shown in experimental and clinical trials. Objective: The present controlled clinical trial was carried out with the objective of determining the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis. Methods: This single-blind randomized clinical trial was performed in Hormozgan in Iran in 2015. Preterm neonates with low birth weight (LBW) were recruited in the study and were randomly divided into two groups. The intervention group received IVIG in addition to routine and general care, including antibiotic treatment, while the control group was given routine and general care without IVIG. IVIG was given to members of the intervention group at slow intravenous infusions at a dose of 500 mg/kg within 12 h and 3 days of birth, respectively. At the end of first week, two groups were compared for mortality rate, total number of days of hospitalization, incidence of intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), and bronchopulmonary dysplasia (BPD). Statistical analysis was conducted by SPSS version 19 using means ± standard deviation, number (%), Chi-square test, and Independent-samples-t-test. Results: A total of 92 infants were enrolled, 46 in intervention and 46 in control group. Administration of IVIG as an adjunctive treatment significantly improved the prevalence of sepsis (0.0487; 95% CI, 0.0027–0.8711, p- value=0.04) and C-reactive protein (0.1869; 95% CI, 0.0380-0.9194, p-value=0.0391) in intervention group in comparison with the control group. No significant differences were observed in IVH, BPD, and NEC between the experimental groups (p-value>0.05). Duration of hospitalization was 13.86 ± 7.31 days in IVIG group and 20.84 ± 11.93 days in control group (p-value<0.05). Conclusion: Prophylactic IVIG is effective in reducing nosocomial infections and duration of hospitalization in preterm and LBW neonates, but has no effect on IVH, BPD, and NEC. We recommend prophylactic IVIG in preterm infants with LBW. Trial registration: The trial is registered at the ClinicalTrials.gov with the identification number NCT02954926. Founding: The authors received financial support from Research Deputy of Hormozgan University of Medical Sciences
Authors and Affiliations
Rakhshaneh Goodarzi, Shaya Dustkhah, Behnaz Khamesan, Seyed Hossein Saadat
Keywords
Related Articles
- EP ID EP350595
- DOI -
- Views 143
- Downloads 0
USABILITY EVALUATION OF ADMISSION INFORMATION SYSTEMS IN MASHHAD UNIVERSITY OF MEDICAL SCIENCES HOSPITALS: A HEURISTIC EVALUATION
Introduction: The admission department is one of the most important hospital departments, where patients contact with the hospital at first and begin assessing hospital services. An admission information system is a part...
A RARE CASE OF PRIMARY HYDATIDOSIS; A PRIMARY PARIETAL PLEURAL HYDATID CYST
Introduction: Hydatid disease is a parasitic disease that mainly affects the liver and the lungs. Primary parietal pleural hydatid disease is a rare variant of this uncommon disease and is rarely reported in medical lite...
DEFINING FACTORS IN USER SATISFACTION WITH HOSPITAL INFORMATION SYSTEM: STRUCTURAL EQUATION MODELING
Introduction: User satisfaction has been considered a measure of information system effectiveness and as a surrogate for the system success. User satisfaction, which is a difficult, intangible, and elusive concept to def...
SINGLE AUTHOR PAPERS IN MASHHAD UNIVERSITY OF MEDICAL SCIENCES (MUMS) IN THE RECENT 10 YEARS
Introduction: Bibliometric analysis can explore the patterns of authorship. The single authorship is an unpleasant phenomenon in research, and we investigate the single author papers’ trend in Mashhad University of Medic...
ONE-YEAR REGISTRY OF ACUTE STEMI PATIENTS IN THREE REFERRAL CARDIOVASCULAR CENTERS IN ISFAHAN 2015 TO 2016
Introduction: We aimed to organize a full data registry and follow-up of patients with ST elevation myocardial infarction (STEMI) admitted to three main cardiac hospitals in Isfahan. These data will be a fundamental basi...