Respiratory Infections Clinical Trial
Official title:
Preventing Respiratory Disease Hospitalizations in Premature Infants Fed Donor Human Milk
Acute respiratory infections are the leading cause of hospitalization in premature infants
worldwide. Severity rates are particularly high in developing countries. Numerous viruses
can cause severe disease, but the most frequent agent of hospitalization is respiratory
syncytial virus (RSV). In a recent study in Argentina, 58% of RSV infected VLBW infants
required hospitalization and 19% required mechanical ventilation. One every twenty infected
infants died. Unlike industrialized nations, VLBW infants in developing countries often lack
access to prophylaxis against RSV with a commercially available monoclonal antibody
(palivizumab). No vaccine or preventive intervention is available against any respiratory
virus for infants younger than 6 months of age in developing countries and the public sector
of most middle-income countries.
The protective role of breastfeeding against respiratory infections in developing countries
is well established. But while similar beneficial effects have been described for premature
infants, the dropout rate for breastfeeding in families exposed to the uncertainties and
stress of the early months of life in the neonatal intensive care unit is very high. The
World Health Organization recommends the use of Human Milk Donor Banks to feed infants that
cannot be breastfed by their own mothers. These banks are established with the purpose of
collecting, screening, processing (including pasteurizing), testing and distributing donated
human milk. The potential benefit of donated milk against acute disease elicited by RSV is
unknown. The investigators propose to study the role of supplemental donated human milk in
the prevention of hospitalizations caused by RSV in non-breastfeeding premature infants.
Since the investigators expect the benefits of breast milk to extend beyond protection
against RSV, the effect of human milk against respiratory infections elicited by other
viruses will also be evaluated.
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