Oral lactoferrin for the prevention of sepsis and necrotizing enterocolitis in preterm infants

Pammi M, Abrams SA

Published Online:

December 7, 2011

Premature babies are at risk from blood infection (sepsis) and/or gastrointestinal injury (necrotizing enterocolitis or NEC). A number of babies with sepsis or NEC die or develop long-term brain and lung injury despite treatment with antibiotics. Lactoferrin, which is present in human milk, has been shown to be effective against infections when tested in animals and in the laboratory. Lactoferrin also enhances the ability of babies to fight infection. This review found one study conducted in Italy that used lactoferrin to prevent sepsis and NEC in preterm infants. In this study, supplementing lactoferrin in the milk of infants weighing less than 1500 g reduced infection after 72 hours of life, but not NEC. We recommend that the findings of this study be confirmed in future studies with respect to safety, dosing, duration and type of lactoferrin in preventing infections and NEC in the preterm babies.

Abstract (click to read)

Background:

Lactoferrin, a normal component of human colostrum, milk, tears and saliva can enhance host defence and may be effective in the prevention of sepsis and necrotizing enterocolitis (NEC) in preterm neonates.

Objectives:

To assess the safety and effectiveness of oral lactoferrin in the prevention of sepsis and NEC in preterm neonates.

Search strategy:

We used the search strategy of the Cochrane Neonatal Review Group (CNRG) including searches of CENTRAL (The Cochrane Library), MEDLINE and PREMEDLINE, EMBASE and CINAHL. We also searched trials registries and the conference proceedings of Pediatric Academic Society. Searches updated in July 2011.

Selection criteria:

Randomized or quasi-randomized controlled trials evaluating oral lactoferrin at any dose or duration for the prophylaxis of sepsis or NEC in preterm neonates.

Data collection and analysis:

Data collection and analysis were performed according to the standard methods of the CNRG.

Main results:

One trial (Manzoni 2009) that randomized 472 very low birth weight infants was eligible. A statistically significant reduction in late-onset sepsis was observed in the groups that received either lactoferrin alone (RR 0.34, 95% CI 0.17 to 0.70) or in combination with Lactobacillus rhamnosus GG (RR 0.27, 95% CI 0.12 to 0.60).

In subgroup analyses, infants weighing less than 1000 g and those fed exclusively on maternal milk had a significant reduction in late-onset sepsis after oral lactoferrin supplementation alone. In the group supplemented with oral lactoferrin and Lactobacillus rhamnosus, infants weighing less than 1000 g had a significant reduction in late-onset sepsis, a result not seen in infants fed maternal milk exclusively.

Prophylaxis with oral lactoferrin alone did not reduce the incidence of NEC (RR 0.33, 95% CI 0.09 to 1.17), but a significant reduction in NEC with a combination of lactoferrin and Lactobacillus rhamnosus GG was noted (RR 0.05, 95% CI 0.00 to 0.90).

No adverse effects due to lactoferrin were observed in this study. Long-term neurological outcomes were not assessed in this trial.

Authors' conclusions:

Oral lactoferrin prophylaxis reduces the incidence of late-onset sepsis in infants weighing less than 1500 g and most effective in infants weighing less than 1000 g. There is no evidence of efficacy of oral lactoferrin (given alone) in the prevention of NEC in preterm neonates.

Well designed, randomized trials should address dosing, duration, type of lactoferrin (bovine or human) prophylaxis in prevention of sepsis and NEC. The effect of exclusive maternal milk feeding should be clarified.

This record should be cited as:

Pammi M, Abrams SA. Oral lactoferrin for the prevention of sepsis and necrotizing enterocolitis in preterm infants. Cochrane Database of Systematic Reviews 2011, Issue 10. Art. No.: CD007137. DOI: 10.1002/14651858.CD007137.pub3

Assessed as up to date:

July 11, 2011

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Primary Review Group:

Neonatal Group

Health topics:

Neonatal care > Neonatal infections > Necrotizing enterocolitis

Neonatal care > Neonatal infections > Other interventions

Complementary & alternative medicine > Neonatal care > Neonatal infections

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Oral lactoferrin for the prevention of sepsis and necrotizing enterocolitis in preterm infants

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