Back to resultsEarly Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
Primary Purpose
Growth in Premature Infants
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
liquid protein supplement
Sponsored by
About this trial
This is an interventional treatment trial for Growth in Premature Infants
Eligibility Criteria
Inclusion Criteria:
- inborn at Mount Sinai Medical Center
- gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
- plan by family for their infant to receive human milk feeds
Exclusion Criteria:
- outborn infants
- gestational age < 26 0/7 weeks or > 33 0/7 weeks
- major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
- sepsis and/or other serious clinical complication precluding initiation of enteral feeds
- plan by family for their infant to receive primarily preterm infant formula.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
liquid protein supplement
Control group
Arm Description
Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day.
Study subjects will receive standard of care nutrition
Outcomes
Primary Outcome Measures
Growth velocity
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
Secondary Outcome Measures
weight
Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU
Length
Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU
head circumference
Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU
Full Information
NCT ID
NCT01991613
First Posted
November 18, 2013
Last Updated
September 21, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT01991613
Brief Title
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
Official Title
Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth in Premature Infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liquid protein supplement
Arm Type
Experimental
Arm Description
Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Study subjects will receive standard of care nutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
liquid protein supplement
Other Intervention Name(s)
Abbott liquid protein supplement
Intervention Description
The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.
Primary Outcome Measure Information:
Title
Growth velocity
Description
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
weight
Description
Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU
Time Frame
average 11 weeks
Title
Length
Description
Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU
Time Frame
average 11 weeks
Title
head circumference
Description
Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU
Time Frame
average 11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
inborn at Mount Sinai Medical Center
gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
plan by family for their infant to receive human milk feeds
Exclusion Criteria:
outborn infants
gestational age < 26 0/7 weeks or > 33 0/7 weeks
major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
sepsis and/or other serious clinical complication precluding initiation of enteral feeds
plan by family for their infant to receive primarily preterm infant formula.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Weintraub, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
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