Probiotic Use Has Increased in Neonatal ICUs, But Further Data Are Still Needed


In neonatal intensive care units, probiotic usage was associated with a decline in necrotizing enterocolitis, but not with sepsis or mortality rates.

Probiotic use has increased in neonatal intensive care units (NICUs) in the United States, according to a study published in JAMA Network Open.

Macro photo of doctor's hands and legs of a child. Newborn is placed in the incubator. Neonatal intensive care unit | Image Credit: Iryna -

Iryna -

In order to understand the impact this may have on birth weight in neonates, investigators aimed to determine whether neonates with very low birth weight who were treated at an NICU that routinely used probiotic would have better outcomes than those in the NICU not treated with probiotics.

The study investigators looked at data from the Vermont Oxford Network on neonates with very low birth weight in NICUs in the United States from January 1, 2012, until December 31, 2019. The data was analyzed from January 2022 through February 2023.

The investigators then assessed the primary outcomes of necrotizing enterocolitis, in-hospital mortality, and sepsis, which was defined as a bacterial or fungal infection occurring after 3 days of birth.

Investigators compared the changes in outcomes for infants with very low birth weight at NICUs before and after hospital-level adoption of probiotics to NICUs that did not adopt probiotic use. An additional analysis was used for the proportion of neonates that were treated with probiotics in each birth year and NICU.

The study data included 307,905 neonates with very low birth weight at 807 hospitals within the United States. In NICUs that adopted hospital-level probiotic use, the rate of probiotic treatment increased from 4.1% in 2012 to 12.6% in 2019.

Investigators found that the incidence of necrotizing enterocolitis declined by approximately 18% at adopting NICUs compared to the trends at nonadopting hospitals.

Additionally, only 16.5% of NICUs adopted probiotics by 2019, with 76.3% receiving probiotics in 2019 at NICUs. Investigators reported that probiotic adoption rates were higher in the West region and lower in the Northeast. For newly adopting NICUs, there was a mean of 3.6 pre-period years and 4.1 post-period years. For those that did not adopt it, there was a mean of 7.8 years.

However, investigators found that probiotic use was not associated with a significant reduction in sepsis or mortality. They also found similar results when excluding NICUs that had already achieved 20% adoption of probiotics by 2012.

The results were also confirmed with an analysis of NICUs that had a 10% probiotic use threshold to define adoption. Additionally, the benefits were smaller than originally predicted by the totality of randomized controlled trial evidence but were consistent with a meta-analysis of studies with a low risk of bias.

Investigators cited limitations with the study, such as it being an observational study. They also noted that a difference-in-differences approach does not rely on comparison at an individual level for those who were treated and untreated in the same NICU during the same year.

Furthermore, investigators were not able to identify a reason for a gap between efficacy of probiotics in clinical trials compared with probiotics in practice in this setting.


Agha L, Staiger D, Brown C, Soll RF, Horbar JD, Edwards EM. Association of hospital adoption of probiotics with otcomes among neonates with very low birth weight. JAMA Health Forum. 2023;4(5):e230960. doi:10.1001/jamahealthforum.2023.0960

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