Abou El Fadl Dina Khaled, Ahmed Marwa Adel, Aly Yasmin Af, Darweesh Ebtissam Abdel Ghaffar, Sabri Nagwa A
Pharmacy Practice & Clinical Pharmacy Department, Faculty of Pharmaceutical Sciences & Pharmaceutical Industries, Future University in Egypt, Cairo, Egypt.
Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
Saudi Pharm J. 2021 Nov;29(11):1314-1322. doi: 10.1016/j.jsps.2021.09.012. Epub 2021 Sep 25.
Preterm neonates have under-developed immune-regulatory system; consequently, there is a risk for developing chronic inflammation. Necrotizing enterocolitis (NEC) is an acute devastating neonatal intestinal inflammatory disorder. Due to the obscure multifactorial etiology, early diagnosis and effective treatment of NEC are limited. Consequently, effective strategies in the prevention of NEC, including nutritional approaches, are critically needed. The current study was conducted to assess the potential immunomodulatory effect of Docosahexaenoic Acid (DHA) supplementation in preterm neonates at neonatal intensive care unit (NICU) and subsequently its effect on preventing or reducing NEC incidence.
This was a prospective randomized controlled study. A total of 67 neonates, with gestational age equal or less than 32 weeks at birth and weight less than or equal 1500 g, were randomly assigned to either DHA group or the control group. Modified Bell's staging criteria for NEC was used as an objective tool for diagnosis and staging of NEC. Levels of Interleukin 1 beta (IL-1β) were measured at baseline and after 10 days. Mortality and NICU length of stay (LOS) were also monitored.
Thirty neonates of each group completed the study. A statistically significant difference was observed between the two groups regarding diagnosis and staging of NEC ( = 0.0001). There was also a statistically significant difference between DHA group 22(73.3), 95% CI [55.9, 86.5] and the control group 8 (26.7), 95% CI [13.5, 44.1] in the percentage change in IL-1β levels ( = 0.0001).A statistically significant association was found between IL and 1 β change and NEC diagnosis ( = 0.001). NICU LOS was significantly lower among DHA group 21.63 ± 6.67 compared to the control group 25.07 ± 4.67 ( = 0.025). Mortality n (%) among the control group 4 (11.8) was higher than DHA group 3 (9.1), however, no significant difference was detected ( = 1.0).
Findings of this study suggest that enteral DHA supplementation can reduce NEC incidence in preterm neonates through its immunoregulatory effect that modulates production of regulatory cytokines. Registered at clinical trials.gov (NCT03700957), 6 October 2018.
早产儿的免疫调节系统发育不完善；因此，存在发生慢性炎症的风险。坏死性小肠结肠炎（NEC）是一种急性严重的新生儿肠道炎症性疾病。由于其病因多因素且尚不明确，NEC的早期诊断和有效治疗受到限制。因此，迫切需要包括营养方法在内的预防NEC的有效策略。本研究旨在评估在新生儿重症监护病房（NICU）中补充二十二碳六烯酸（DHA）对早产儿的潜在免疫调节作用，以及随后其对预防或降低NEC发病率的影响。
这是一项前瞻性随机对照研究。共有67例出生时胎龄小于或等于32周、体重小于或等于1500g的新生儿被随机分为DHA组或对照组。采用改良的贝尔NEC分期标准作为NEC诊断和分期的客观工具。在基线和10天后测量白细胞介素1β（IL-1β）水平。还监测了死亡率和NICU住院时间（LOS）。
每组30例新生儿完成了研究。两组在NEC的诊断和分期方面存在统计学显著差异（P = 0.0001）。DHA组[22（73.3），95%可信区间[55.9，86.5]]和对照组[8（26.7），95%可信区间[13.5，44.1]]的IL-1β水平变化百分比也存在统计学显著差异（P = 0.0001）。发现IL-1β变化与NEC诊断之间存在统计学显著关联（P = 0.001）。DHA组的NICU住院时间为21.63±6.67，显著低于对照组的25.07±4.67（P = 0.025）。对照组的死亡率为4（11.8）%，高于DHA组的3（9.1）%，然而，未检测到显著差异（P = 1.0）。
本研究结果表明，肠内补充DHA可通过调节调节性细胞因子的产生，发挥免疫调节作用，从而降低早产儿的NEC发病率。于2018年10月6日在clinicaltrials.gov注册（NCT03700957）。
