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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Fortification of breastmilk with liquid human milk fortifier in premature infants
Pontificia universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
RECRUITINGWeight 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
Time frame: between entering study and 45 days in study or discharge, whatever first
Compare length of hospital- stay
days from the first day of study to discharge home ( weight is one criteria for discharge)
Time frame: days from the first day of study to discharge home , an average of 37 weeks of postconceptual age
Compare feeding tolerance
Daily record of residue, regurgitation and suspend of gastric feedings
Time frame: 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
Time frame: 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.
Time frame: Between entering study and 45 days in study or discharge, if discharge is first
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