In RCTs , pasteurized human donor milk , as opposed to formula , reduced NEC but not infections or mortality .
Pooled data of small trials and a recent large RCT suggested that bovine lactoferrin reduced rates of fungal sepsis without impact on other infections , NEC , or mortality .
Pooled data of RCTs assessing the use of prebiotic oligosaccharides found reduced infection but not mortality .
A meta- analysis sensitivity approach found multiple-strain ( but not single-strain ) probiotics to be highly effective in reducing NEC and mortality .
Thus , selected food components may help to improve outcomes in preterm infants
Observational studies demonstrating reduced rates of infections , necrotizing enterocolitis ( NEC ) , and mortality in preterm infants fed their own mother ’s milk , as opposed to formula , have prompted endeavors to achieve similar effects with the right choice of food and food additives .
In a systematic review of meta-analyses and r and omized controlled trials ( RCTs ) , we considered nutritional interventions aim ed at reducing the rates of infections , NEC , or mortality in very preterm infants .
Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial
Summary Background Infections acquired in hospital are an important cause of morbidity and mortality in very preterm infants . Several small trials have suggested that supplementing the enteral diet of very preterm infants with lactoferrin , an antimicrobial protein processed from cow 's milk , prevents infections and associated complications . The aim of this large r and omised controlled trial was to collect data to enhance the validity and applicability of the evidence from previous trials to inform practice . Methods In this r and omised placebo-controlled trial , we recruited very preterm infants born before 32 weeks ' gestation in 37 UK hospitals and younger than 72 h at r and omisation . Exclusion criteria were presence of a severe congenital anomaly , anticipated enteral fasting for longer than 14 days , or no realistic prospect of survival . Eligible infants were r and omly assigned ( 1:1 ) to receive either enteral bovine lactoferrin ( 150 mg/kg per day ; maximum 300 mg/day ; lactoferrin group ) or sucrose ( same dose ; control group ) once daily until 34 weeks ' postmenstrual age . Web-based r and omisation minimised for recruitment site , gestation ( completed weeks ) , sex , and single versus multifetal pregnancy . Parents , caregivers , and outcome assessors were unaware of group assignment . The primary outcome was microbiologically confirmed or clinical ly suspected late-onset infection ( occurring > 72 h after birth ) , which was assessed in all participants for whom primary outcome data was available by calculating the relative risk ratio with 95 % CI between the two groups . The trial is registered with the International St and ard R and omised Controlled Trial Number 88261002 . Findings We recruited 2203 participants between May 7 , 2014 , and Sept 28 , 2017 , of whom 1099 were assigned to the lactoferrin group and 1104 to the control group . Four infants had consent withdrawn or unconfirmed , leaving 1098 infants in the lactoferrin group and 1101 in the sucrose group . Primary outcome data for 2182 infants ( 1093 [ 99·5 % ] of 1098 in the lactoferrin group and 1089 [ 99·0 ] of 1101 in the control group ) were available for inclusion in the modified intention-to-treat analyses . 316 ( 29 % ) of 1093 infants in the intervention group acquired a late-onset infection versus 334 ( 31 % ) of 1089 in the control group . The risk ratio adjusted for minimisation factors was 0·95 ( 95 % CI 0·86–1·04 ; p=0·233 ) . During the trial there were 16 serious adverse events for infants in the lactoferrin group and 10 for infants in the control group . Two events in the lactoferrin group ( one case of blood in stool and one death after intestinal perforation ) were assessed as being possibly related to the trial intervention . Interpretation Enteral supplementation with bovine lactoferrin does not reduce the risk of late-onset infection in very preterm infants . These data do not support its routine use to prevent late-onset infection and associated morbidity or mortality in very preterm infants . Funding UK National Institute for Health Research Health Technology Assessment programme ( 10/57/49 )
In RCTs , pasteurized human donor milk , as opposed to formula , reduced NEC but not infections or mortality .
Pooled data of small trials and a recent large RCT suggested that bovine lactoferrin reduced rates of fungal sepsis without impact on other infections , NEC , or mortality .
Pooled data of RCTs assessing the use of prebiotic oligosaccharides found reduced infection but not mortality .
A meta- analysis sensitivity approach found multiple-strain ( but not single-strain ) probiotics to be highly effective in reducing NEC and mortality .
Thus , selected food components may help to improve outcomes in preterm infants
Observational studies demonstrating reduced rates of infections , necrotizing enterocolitis ( NEC ) , and mortality in preterm infants fed their own mother ’s milk , as opposed to formula , have prompted endeavors to achieve similar effects with the right choice of food and food additives .
In a systematic review of meta-analyses and r and omized controlled trials ( RCTs ) , we considered nutritional interventions aim ed at reducing the rates of infections , NEC , or mortality in very preterm infants .