Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Not Applicable

Completed

• Conditions: Infant, Premature, Diseases
• Interventions: Dietary Supplement: human milk fortifier

• Registration Number: NCT01731613
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-22
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-25
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjustable fortification	human milk fortifier	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)
Standard Fortification	human milk fortifier	receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study

Primary Outcome Measures

Name	Time	Method
The weight gain velocity during hospitalization	participants will be followed until discharge, an expected average of 2 weeks	The weight gain velocity(g/kg/d)
Time to reach 100kcal/kg/d of enteral nutrition	participants will be followed until discharge, an expected average of 2 weeks	Days to reach 100kcal/kg/d of enteral nutrition

Secondary Outcome Measures

Name	Time	Method
metabolic indicators after enrollment, including BUN,prealbumin, albumin	participants will be followed until discharge, an expected average of 2 weeks	BUN(mmol/L), prealbumin(mg/L), albumin(g/L)
The protein and energy ratio of enteral nutrition each week after enrollment	participants will be followed until discharge, an expected average of 2 weeks	The protein and energy ratio(g/100kcal)
Time to reach 2000g of body weight	participants will be followed until discharge, an expected average of 2 weeks	Days to reach 2000g of body weight

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China