Human Milk Fortification in Very Low Birth Neonates

Enteral Nutrition Clinical Trial

Official title:

Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988792
• Other study ID #: 13-02741-FB
• Secondary ID: 8671-2075
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: July 28, 2015
• Start date: November 2013
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

Description:

Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).

Exclusion Criteria:

• Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.

• Died or extended to die within 48 hours of life

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enteral Nutrition
• Fortification
• Human Milk
• Premature; Infant

Intervention

Dietary Supplement:
• Human milk fortifiers

Locations

Country	Name	City	State
United States	University of Tennessee, Health Science Center, The Regional Medical Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The days to reach full enteral feeding volume (140 ml/kg/day).		4 - 6 weeks	Yes
Secondary	Neonatal Outcomes	Necrotizing Enterocolitis	until 36 weeks PMA	Yes
Secondary	Neonatal Outcomes	Chronic Lung Disease	until 36 weeks PMA	No
Secondary	Neonatal Outcomes	Feeding intolerance	Until full feeding volume	Yes
Secondary	Neonatal Outcomes	Parental nutrition days	Until full feeding volume	No
Secondary	Neonatal Outcomes	Ventilator days	until 36 weeks PMA	No
Secondary	Neonatal Outcomes	Protein and caloric intake	until 4 weeks of life	No
Secondary	Neonatal Outcomes	Growth anthropometry	until 4 weeks of life	No