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Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants

NCT01390753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-02-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Human donor milk

Sponsors & Collaborators

  • Fundacion Infant

    lead OTHER

Principal Investigators

  • Fernando P Polack, MD · Fundacion Infant

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01390753 on ClinicalTrials.gov