Journal club · Invited commentary
Weighing risks and benefits in the very preterm infant
Welcome, and thank you for joining. Since the FDA warning in 2023, most units quietly stopped giving probiotics to preterm babies — and that decision traded one risk for another. Over the next twenty minutes I want us to look at the largest safety study published so far, weigh it honestly against what NEC costs these babies every year, and then ask the harder question: what would any of this mean for our own unit?
14 slides · about 20 minutes · speaker notes included
Scottoline B, Jordan BK. JAMA Network Open. 2026;9(7):e2626535
Journal club · Invited commentary
Weighing risks and benefits in the very preterm infant
Scottoline B, Jordan BK.
JAMA Network Open. 2026;9(7):e2626535. Published July 31,
2026
Commentary on: Patel RM et al. JAMA Netw Open.
2026;9(7):e2626530
Presented by Dr. Kashaf Qudoos
The question on the table
After the 2023 FDA warning, most US NICUs stopped giving probiotics to prevent NEC. That choice swaps one risk for another. These papers let us measure both.
Blood infection from probiotics
Necrotizing enterocolitis
Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535.
The new evidence
Nearly 20 000 very preterm babies studied — the largest such study published so far
Babies born before 32 weeks made up the very preterm (VPT) group
The Pediatrix NICU network covers about 30% of all NICU babies in the United States
The babies were given probiotics by mouth containing Lactobacillus and/or Bifidobacterium.
Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535.
Finding 1 — the safety signal
These numbers match earlier, smaller studies and make the estimate more exact.
Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535.
Finding 2 — the same result elsewhere
| Study | Babies studied | Blood infection from probiotics | Deaths linked to probiotics |
|---|---|---|---|
| Patel et al 2026 |
Very preterm, GA <32 wk (~19 900 babies) |
0.04% (≈1 in 2500) |
1 in 19 900 |
| Alshaikh et al 2025 |
GA <34 wk Extremely low birth weight <1000 g |
0.14% 0.4% in ELBW |
≈1 in 6300 |
| Feldman et al 2025 |
Preterm babies (meta-analysis) |
<0.04% | Potentially 1 in 20 323 |
Different networks, countries and methods — all landing on roughly the same number.
Patel et al 2026; Alshaikh et al, Pediatrics 2025;155(3):e2024069102; Feldman et al, Pediatr Res 2025.
The other side of the scale
VLBW = very low birth weight (<1500 g). Most of these babies are also very preterm.
NEC is a severe inflammatory disease of the baby's gut, and there is still no approved treatment for it.
Wolf MF et al. JAMA Netw Open. 2023;6(3):e231511; Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535.
How NEC happens
The preterm immune system reacts too strongly. The gut expects almost sterile amniotic fluid.
The gut fills with bacteria picked up in the NICU, with too many Proteobacteria.
TLR4 binds bacterial lipopolysaccharide and sets off heavy inflammation in the gut lining.
Immune cells activate, blood vessels narrow, and the gut nerves stop working properly.
The gut can perforate, leading to peritonitis, sepsis, shock and sometimes death.
Because of this, NEC in VLBW babies is often called “dysbiotic NEC” — one type of preterm gut injury.
Cuna A et al. Front Pediatr. 2024; Hackam DJ, Sodhi CP. Nat Rev Gastroenterol Hepatol. 2022.
Beyond death rates
Babies who survive NEC live with the effects for life. Death rates alone hide how much harm it does.
White matter brain injury and delayed development
Long-term gut problems, including short gut syndrome
Higher risk of chronic lung disease
A heavy emotional toll on families that we rarely measure
Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535.
What the FDA did
Up to 40% of US NICUs were giving probiotics to prevent NEC
Growing use, plus scattered reports of infection and possible death, led the FDA to warn against giving live bacteria to preterm babies outside a formal research licence
Probiotic use in US preterm babies almost completely stopped
Some units that stopped report more NEC — but we do not know whether this holds true everywhere
US Food and Drug Administration, September 29, 2023; Scottoline B, Jordan BK. JAMA Netw Open. 2026.
The central comparison
NEC happens roughly 30 to 300 times more often than blood infection caused by probiotics.
Death from NEC is roughly 60 to 200 times more common than death from a probiotic infection.
Comparison derived from Patel et al 2026, Alshaikh et al 2025 and Feldman et al 2025.
What it means
More than 36 randomised trials disagree in the detail, but point the same way: probiotics may lower NEC
Even in fragile very preterm babies, the risk of harm stays low
The disease we prevent is 10 to 100 times more common, and more deadly, than the harm we fear
Sharif S et al. Cochrane Database Syst Rev. 2023; Scottoline B, Jordan BK. JAMA Netw Open. 2026.
Caveats and next steps
Not a trial
This is registry data, not a randomised study designed to measure safety
Patchy reporting
Probiotic trials have never collected safety data in the same way
Products differ
Strains, mixtures and manufacturing quality vary widely between brands
Big trials
Trials large enough to test whether probiotics really prevent NEC in VLBW babies
Approval as a drug
Licensing them as drugs would bring quality standards and proper oversight
Ongoing monitoring
Tracking patients after approval to sharpen the risk numbers
Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535.
Bringing it home
The FDA warning does not apply in Pakistan — but we have the same missing evidence.
Track NEC and late sepsis in our VLBW babies for 6–12 months. This gives us the baseline numbers we do not have.
A small group given probiotics, watched closely for blood infection. Checks we can spot the harm before testing the benefit.
Testing NEC properly needs more babies than one unit has. Only possible with other Punjab tertiary NICUs.
How many babies?
Our yearly VLBW and very preterm admissions, and our own NEC rate — to be taken from unit records
Can the lab detect it?
Can our lab grow and identify Lactobacillus and Bifidobacterium from blood? Anaerobic culture is the main hurdle
Can we get the product?
A probiotic with known strains, batch checks and an unbroken cold chain — the hardest part to arrange
Approvals
DRAP status of the product, ethics committee approval, and a clear consent process
We cannot answer whether probiotics work on our own. But we can answer the first question nobody here has answered: what is our own NEC rate?
Local feasibility — figures still to be confirmed from unit records.
Closing
Scottoline and Jordan end by repeating a parent's point: infection from probiotics is a real danger, but a rare one. NEC is by far the more likely threat to these babies.
A point made by Jennifer Canvasser — mother of a baby who died of NEC, and founder of the NEC Society
Scottoline B, Jordan BK. JAMA Netw Open. 2026;9(7):e2626535. Full reference list available on request.