What are the benefits and risks of giving lactoferrin to full-term babies who had digestive tract surgery?

Key message

We found no medical studies that investigated the effects of giving lactoferrin (a protein found in milk) to babies born at full-term (at or after 37 weeks of pregnancy) who had surgery of their digestive tract.

What is lactoferrin?

Lactoferrin is a protein found in milk that can protect against infection. Lactoferrin supplements are available and have been researched in premature babies. There is some evidence that lactoferrin can prevent infection in premature babies.

What are some of the risks of digestive tract surgery in babies?

Surgery of the digestive tract increases the risk of infection. Infections can increase the length of stay in hospital. Treatment with antibiotics (medicines that fight bacterial infections) and stress from surgery can disrupt good bacteria in the digestive tract.

What did we want to find out?

We wanted to find out if giving lactoferrin to full-term babies, after digestive tract surgery, decreased rates of infection and death, and improved the presence of good bacteria in the digestive tract.

What did we do?

We searched for studies in which babies who had digestive tract surgery were assigned randomly to lactoferrin or a placebo (a 'dummy' treatment that does not contain any medicine but looks or tastes the same as the medicine being tested).

What did we find?

We did not find any studies that compared giving lactoferrin to a placebo in full-term babies who had digestive tract surgery. Well-designed and large studies are needed to answer this question. 

How up to date is this evidence?

The search is up-to-date as of February 2023.

Authors' conclusions: 

There is currently no evidence available from randomised controlled trials to show whether lactoferrin is effective or ineffective for the postoperative management of term neonates after gastrointestinal surgery. There is a need for randomised controlled trials to be performed to assess the role of lactoferrin in this setting.

Read the full abstract...

Neonates who have undergone gastrointestinal surgery are particularly susceptible to infectious complications in the postoperative period. This may be due in part to disruption of the integrity of the gut and its altered intestinal microflora. Lactoferrin is a whey protein found in milk and is an important innate mammalian defence mechanism. Lactoferrin has been reported to have antimicrobial and anti-inflammatory properties. It has also been reported to help establish a healthy gut microflora and aid in the intestinal immune system. Lactoferrin supplementation has been reported to decrease sepsis in preterm infants. There may be a role for lactoferrin to reduce the incidence of sepsis, thus reducing morbidity and mortality and improving enteral feeding in postoperative term neonates.


The primary objective of this review was to evaluate the efficacy of administering lactoferrin on the incidence of sepsis and mortality in term neonates after gastrointestinal surgery.

The secondary objective was to assess the impact of administering lactoferrin on time to full enteral feeds, the intestinal microflora, duration of hospital stay, and mortality before discharge in the same population.

Search strategy: 

The Cochrane Neonatal Information Specialist searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase Ovid, CINAHL, the WHO ICTRP and ClinicalTrials.gov trials registries. The date of the last search was February 2023. There were no restrictions to language, publication year or publication type. We checked references of potentially relevant studies and systematic reviews.

Selection criteria: 

We planned to include randomised controlled trials that studied infants born at 37 or more weeks of gestation who had one or more episodes of gastrointestinal surgery within 28 days of birth, and compared administration of lactoferrin with a placebo.

Data collection and analysis: 

We used standard Cochrane methodological procedures. We planned to use the GRADE approach to assess the certainty of evidence for each outcome.

Main results: 

We identified no published randomised controlled studies that assessed the efficacy of lactoferrin for the postoperative management of term neonates following gastrointestinal surgery.