EvidenceHealthNutritionInfection models

Raw vs Pasteurised Human Milk & Neonatal Infections

Study type:
Randomised clinical feeding trial in neonates
Topic:
Raw vs Holder‑pasteurised human milk and infection risk in newborns
Added:
2025-12-23
Status:
published

Strength of evidence

Moderate – experimental design with hard clinical endpoints, but no pure null control and incomplete blinding details by modern standards.

Source

Narayanan I, Prakash K, Murthy NS, Gujral VV. Randomised controlled trial of effect of raw and Holder pasteurised human milk and of formula supplements on incidence of neonatal infection. Lancet. 1984;2(8412):1111–1113.

Open original study

In this randomised hospital study, newborns were allocated to feeding regimens based on their own mother's raw milk, Holder‑pasteurised human milk or formula supplements. Infants who received mostly raw human milk had the lowest infection rates, those on pasteurised milk had intermediate risk, and formula‑supplemented babies did worst. The trial provides moderate‑quality experimental evidence that raw human milk offers stronger protection against early infections than processed alternatives.

Key findings

  • Neonates were randomised to different feeding schemes involving raw human milk, Holder‑pasteurised milk and/or formula.
  • The raw‑milk group showed the lowest incidence of neonatal infections and serious complications.
  • The pasteurised‑milk group had higher infection rates than the raw‑milk group, but lower than the formula‑supplement group.
  • The formula‑supplement group had the highest overall burden of infections.
  • Outcomes were hard clinical endpoints: diagnosed infections and neonatal morbidity.

Background

  • Pasteurisation is used to reduce microbial contamination in milk, but it can damage immune components. Narayanan and colleagues asked: How do different feeding strategies – raw human milk, Holder‑pasteurised human milk, and formula supplements – affect the incidence of infections in newborns?

Methods

  • Setting: neonatal unit in a hospital. Groups (simplified): Group 1 (predominantly raw milk from the infant's own mother), Group 2 (Holder‑pasteurised human milk, mostly donor milk), Group 3 (formula supplements, sometimes combined with limited human milk). Randomisation: infants were assigned to these feeding strategies using allocation procedures of the time. Follow‑up: early neonatal period, when infection risk is highest. Endpoints (hard clinical outcomes): number of diagnosed infections (e.g. sepsis), serious neonatal complications and morbidity.

Results

  • Infants in the raw‑milk group had the lowest infection incidence, fewer severe illness episodes. Infants in the pasteurised‑milk group had higher infection rates than raw‑milk infants, but less infection than those receiving formula supplements. Infants in the formula‑supplement group had highest infection rates and overall complication burden. The results show a clear gradient in early infection protection: raw human milk > pasteurised human milk > formula.

Interpretation

  • For WorthDay, S26 is a strong human intervention example: It uses randomisation and focuses on hard clinical endpoints (infections, serious illness), it supports the hypothesis that raw human milk provides unique immunological benefits that pasteurisation weakens and formula lacks. However: complete blinding of staff and possibly parents was not feasible, no pure "no‑feeding" null control is possible for ethical reasons, the study reflects feeding practices and formula composition of its time. Therefore, S26 is rated 🟡 moderate evidence quality – robustly supporting raw human milk in this context, while leaving space for further, more modern trials.

Limitations

  • Staff were not fully blinded to feeding type; handling or co‑interventions might have differed slightly.
  • All infants received some form of nutritional intervention; a pure null control (no feeding) is impossible.
  • Formula composition and hygiene standards may differ from current products and practices.
  • Long‑term developmental outcomes were not the primary focus and are less well documented.

WorthDay perspective

  • Together with S01, S26 provides WorthDay with human experimental support for: "For newborns, raw human milk appears to be superior to both pasteurised human milk and formula in preventing early infections."
  • This aligns with WorthDay's emphasis on: biologically appropriate, minimally processed primary foods, caution regarding industrial substitutes for species‑specific nutrition, especially in vulnerable life stages.
  • In Health and Foodlovers content, S26 can be used to: explain why WorthDay favours whole, unprocessed foods over processed "equivalents", show concretely what a relatively strong clinical trial looks like (randomisation, hard endpoints).

Permalink: https://www.worth-day.com/science-compass/s0026-raw-vs-pasteurised-human-milk-neonatal-infections

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