Scholarlink

Objective <p>To evaluate changes in probiotic use and necrotizing enterocolitis (NEC) in preterm infants following the 2023 FDA actions.</p> Study design <p>Natural experiment observational study of preterm infants from the Pediatrix Clinical Data Warehouse comparing NEC among infants in high probiotic-use (HUC) centers versus low-use centers (LUC) using difference-in-differences analyses from October 2022–September 2023 to April 2024–March 2025.</p> Results <p>There were 2785 infants in the HUCs and 7298 infants in the LUCs. After FDA action, probiotic use decreased in HUCs (86–6.9%); the decrease was smaller in LUCs (13–0.1%). NEC incidence increased in HUCs (2.7–4.4%), but remained unchanged in LUCs at 3.6% (adjusted difference-in-difference in NEC in HUCs compared to LUCs: 1.18%; 95% CI 0.03–2.33%, <i>P</i> = 0.045).</p> Conclusion <p>NEC incidence increased in centers routinely using probiotics after rapid cessation of use following FDA actions.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Probiotics and necrotizing enterocolitis in preterm infants after the food and drug administration warning actions

  • 期刊论文

  • 发表日期：

    2026年6月2日

查看全文
  • Veeral N. Tolia,
  • Monica M. Bennett,
  • Darren Handler,
  • Jennifer Canvasser,
  • Rachel G. Greenberg,
  • Robert Ursprung,
  • Kaashif A. Ahmad,
  • Ravi M. Patel

摘要

Objective

To evaluate changes in probiotic use and necrotizing enterocolitis (NEC) in preterm infants following the 2023 FDA actions.

Study design

Natural experiment observational study of preterm infants from the Pediatrix Clinical Data Warehouse comparing NEC among infants in high probiotic-use (HUC) centers versus low-use centers (LUC) using difference-in-differences analyses from October 2022–September 2023 to April 2024–March 2025.

Results

There were 2785 infants in the HUCs and 7298 infants in the LUCs. After FDA action, probiotic use decreased in HUCs (86–6.9%); the decrease was smaller in LUCs (13–0.1%). NEC incidence increased in HUCs (2.7–4.4%), but remained unchanged in LUCs at 3.6% (adjusted difference-in-difference in NEC in HUCs compared to LUCs: 1.18%; 95% CI 0.03–2.33%, P = 0.045).

Conclusion

NEC incidence increased in centers routinely using probiotics after rapid cessation of use following FDA actions.