Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Peking Union Medical College Hospital51 enrolled

Overview

This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Infant, Premature, Diseases

Interventions

human milk fortifierDIETARY_SUPPLEMENT

Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen

Eligibility

Sex: ALLMin age: 10 DaysMax age: 40 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Less than 34 weeks gestational age at birth * Birth weight within 800-1800 grams * Exclusively or mostly breastfed (greater than 80% if the feeding volume) * Tolerated enteral feedings of 60 ml/kg/d * Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment * Signed Informed Consent Exclusion Criteria: * Small for gestational age * Infants currently receiving ventilation therapy * Major congenital malformations * Suspected or documented systemic or congenital infections * Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth * Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia * Suspected or documented maternal substance abuse * Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China