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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


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
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