An interventional study of Human donor milk in Respiratory Infections, sponsored by Fundacion Infant. Completed at 1 site in Argentina. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2017-02-14.
Sponsored by Fundacion Infant · Not applicable, Interventional, and Prevention
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.
1,052 studies on the registry are indexed under Respiratory Tract Infections; 147 are open to participants now.
This study's enrollment of 300 is above the median of 196 across 715 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Fundacion Infant is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Human milk from a donor bank
Dietary Supplement: Human donor milk
Number of respiratory episodes in premature infants
Time frame: During the first year of life
Plan to share: No
The record gives a start of Apr 2012, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
Fundacion Infant