| Methods | Controlled phase 4 trial of lactoferrin supplementation in preterm infants |
| Participants | Newborn infants with birth weight ≤ 1500 g and/or gestational age ≤ 32 weeks Exclusion criteria: fetal‐onset disorders and/or recognizable at birth, milk intolerance, family history of allergy, use of infant formula supplemented with lactoferrin |
| Interventions | Intervention group (n = 650) received a daily dose of 100 mg of lactoferrin + standard therapy; control group (n = 650) received only standard therapy |
| Outcomes | Primary outcome: evaluation of the antioxidant effect of lactoferrin and its ability to reduce free radical‐related disease in the newborn through assessment of neurodevelopmental follow‐up Secondary outcome: identification of a panel of markers for assessing oxidative stress and for correlating with the lactoferrin antioxidant effect |
| Notes | We have requested details of the study from the principal investigator Trial ID: ClinicalTrials.gov identifier: NCT01172236 |
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