Clinical trial NCT01731613: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
Official title: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2012-11-22
Enrollment: 51
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to reach 100kcal/kg/d of enteral nutrition
timeFrame: participants will be followed until discharge, an expected average of 2 weeks
measure: The weight gain velocity during hospitalization
timeFrame: participants will be followed until discharge, an expected average of 2 weeks
Secondary outcomes:
measure: The protein and energy ratio of enteral nutrition each week after enrollment
timeFrame: participants will be followed until discharge, an expected average of 2 weeks
measure: Time to reach 2000g of body weight
timeFrame: participants will be followed until discharge, an expected average of 2 weeks
measure: metabolic indicators after enrollment, including BUN,prealbumin, albumin
timeFrame: participants will be followed until discharge, an expected average of 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Danhua Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: