Evidence map›Paper›PMID 42225922›Full record

ArticleJournal of perinatology : official journal of the California Perinatal Association2026

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

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

Erratum issuedAbstract read
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In one paragraph

Article in Journal of perinatology : official journal of the California Perinatal Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Veeral N ToliaPediatrix Center for Research Education, Quality and Safety, Sunrise, FL, USA. veeraltolia@gmail.com.ORCID http://orcid.org/0000-0002-6841-4862
Monica M BennettBaylor Scott & White Research Institute, Dallas, TX, USA.
Darren HandlerPediatrix Center for Research Education, Quality and Safety, Sunrise, FL, USA.
Jennifer CanvasserNEC Society, Davis, CA, USA.
Rachel G GreenbergDepartment of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Robert UrsprungPediatrix Center for Research Education, Quality and Safety, Sunrise, FL, USA.
Kaashif A AhmadPediatrix Center for Research Education, Quality and Safety, Sunrise, FL, USA.
Ravi M PatelDepartment of Pediatrics, Emory University and Children's Healthcare of Atlanta, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-7444-5550

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

designNatural 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.

resultsThere 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).

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

Identifiers

PMID42225922

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.