Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Infant, Premature, Diseases

Treatments: Dietary Supplement: human milk fortifier

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01731613

8648

Details and patient eligibility

About

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

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 10 to 40 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Standard Fortification

Active Comparator group

Description:

receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study

Treatment:

Dietary Supplement: human milk fortifier

Adjustable fortification

Experimental group

Description:

encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)

Treatment:

Dietary Supplement: human milk fortifier