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

Respiratory Infections Clinical Trial

Official title:

Preventing Respiratory Disease Hospitalizations in Premature Infants Fed Donor Human Milk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390753
• Other study ID #: INFANT-001
• Secondary ID: Donor milk study
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: February 13, 2017
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Fundacion Infant
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• VLBW preterm neonates (birth weight <1,500 g at birth; gestational age <37 weeks) born alive at any of the two participating maternity hospitals integrating our network in Argentina will be enrolled in the study after signature of informed consent.

Exclusion Criteria:

• VLBW infants older than one month of age (e.g.: transferred from another institution), or formula fed for over ten days, or with congenital heart disease, congenital anomalies of the respiratory tract (i.e.: tracheoesophageal fistula, pulmonary hypoplasia, diaphragmatic hernia), immune suppression, severe malformations affecting breathing (i.e. anencephaly) as well as infants who die prior to completion of the first questionnaire, or living more than 40 km away from the Hospital will be excluded from participation. Infants born from human immunodeficiency virus (HIV) positive mothers will also be excluded

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Infections
• Respiratory Tract Diseases
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Human donor milk

Locations

Country	Name	City	State
Argentina	Fundacion INFANT	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Infant

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of respiratory episodes in premature infants		During the first year of life