Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to compare two human milk fortifiers with different protein content and LCPUFA in a group of very low birth weight infants.
This study is a multi-center, third party-blinded, randomized, controlled, parallel- group, prospective trial comparing growth with a liquid human milk fortifier with higher protein content and LCPUFA and a control powdered human milk fortifier added to breast milk and fed to premature infants. The trial will be conducted in 11 centers in Chile. The enrollment period is expected to be approximately 18 months. To allow for dropouts, approximately 160 participants will be randomized.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid human milk fortifier | Experimental | Liquid human milk fortifier which has higher protein content and also LCPUFA |
|
| Powder human milk fortifier | Active Comparator | Powder human milk fortifier with less protein content and no LCPUFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human milk fortifier | Dietary Supplement | Fortification of breastmilk with liquid human milk fortifier in premature infants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight and linear growth | Weight increase in g/K/day and knee-to-heel length increase in mm/weeks, measured in one scale (+-5 g) and one kneenometer (special device to measure longitude) (+- 1mm) by one person for each center between entering study and 45 days in study or discharge | between entering study and 45 days in study or discharge, whatever first |
| Measure | Description | Time Frame |
|---|---|---|
| Compare length of hospital- stay | days from the first day of study to discharge home ( weight is one criteria for discharge) | days from the first day of study to discharge home , an average of 37 weeks of postconceptual age |
| Compare feeding tolerance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Masoli, MD | Contact | 56-9-95453952 | daniela.masoli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Mena, MD | Hospital Sotero Del Rio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia universidad Catolica de Chile | Recruiting | Santiago | Santiago Metropolitan | 8330024 | Chile |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Daily record of residue, regurgitation and suspend of gastric feedings
| Between entering study and 45 days in study or discharge, if discharge first |
| Compare incidence of main preterm morbidities: necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and sepsis | Incidence of necrotizing enterocolitis grade II or more, bronchopulmonary dysplasia as additional oxygen at 36 postconceptual weeks, retinopathy of prematurity with treatment and sepsis with positive hemoculture | Between entering study and 45 days in study or discharge, if discharge is first |
| Compare cost/benefits . The cost of use a fortificant and the benefit of growth velocity | compare cost of total amount of fortifier used compare with cost of number of days of hospitalization, number of days in neonatal intensive care unit in each group. | Between entering study and 45 days in study or discharge, if discharge is first |