Effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis: a clinical trial study

  • سال انتشار: 1397
  • محل انتشار: نوزدهمین کنگره پژوهشی سالانه دانشجویان علوم پزشکی کشور
  • کد COI اختصاصی: AMSMED19_192
  • زبان مقاله: انگلیسی
  • تعداد مشاهده: 682
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نویسندگان

Romina Rezaei

Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

Rakhshaneh Goodarzi

Neonatologist, Clinical Research Development Center of Children Hospital,Hormozgan University of Medical Sciences, Bandar Abbas, Iran

Shaya Dustkhah

Neonatologist, Clinical Research Development Center of Children Hospital,Hormozgan University of Medical Sciences, Bandar Abbas, Iran

Behnaz Khamesan

Neonatologist, Clinical Research Development Center of Children Hospital,Hormozgan University of Medical Sciences, Bandar Abbas, Iran

چکیده

Background and Objective: 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. The present controlled clinical trial was carried out with the objective of determining the effect ofintravenous immunoglobulin in prevention of preterm neonatal sepsis.Materials and 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. The trial is registered at the ClinicalTrials.gov with the identification number NCT02954926. Findings :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, pvalue= 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.

کلیدواژه ها

Intravenous immunoglobulin, Neonatal sepsis, Intraventricular hemorrhage, Necrotizing enterocolitis, Bronchopulmonary dysplasia

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