Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Infant, Premature, Diseases Clinical Trial

Official title:

Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731613
• Other study ID #: 8648
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 25, 2017
• Start date: August 2012
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Dietary Supplement:
• human milk fortifier
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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Mead Johnson Nutrition

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach 100kcal/kg/d of enteral nutrition	Days to reach 100kcal/kg/d of enteral nutrition	participants will be followed until discharge, an expected average of 2 weeks
Primary	The weight gain velocity during hospitalization	The weight gain velocity(g/kg/d)	participants will be followed until discharge, an expected average of 2 weeks
Secondary	The protein and energy ratio of enteral nutrition each week after enrollment	The protein and energy ratio(g/100kcal)	participants will be followed until discharge, an expected average of 2 weeks
Secondary	Time to reach 2000g of body weight	Days to reach 2000g of body weight	participants will be followed until discharge, an expected average of 2 weeks
Secondary	metabolic indicators after enrollment, including BUN,prealbumin, albumin	BUN(mmol/L), prealbumin(mg/L), albumin(g/L)	participants will be followed until discharge, an expected average of 2 weeks