Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Primary Purpose
Respiratory Infections
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Human donor milk
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Infections
Eligibility Criteria
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
Sites / Locations
- Fundacion INFANT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
No Intervention
No Intervention
Arm Label
Preterm formula
Donor milk + preterm formula
Breastfeeding + formula
Breasfeeding
Arm Description
Human milk from a donor bank
Outcomes
Primary Outcome Measures
Number of respiratory episodes in premature infants
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01390753
Brief Title
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Official Title
Preventing Respiratory Disease Hospitalizations in Premature Infants Fed Donor Human Milk
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Infant
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preterm formula
Arm Type
No Intervention
Arm Title
Donor milk + preterm formula
Arm Type
Active Comparator
Arm Description
Human milk from a donor bank
Arm Title
Breastfeeding + formula
Arm Type
No Intervention
Arm Title
Breasfeeding
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Human donor milk
Primary Outcome Measure Information:
Title
Number of respiratory episodes in premature infants
Time Frame
During the first year of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando P Polack, MD
Organizational Affiliation
Fundacion Infant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion INFANT
City
Buenos Aires
ZIP/Postal Code
1406
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
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