Evaluation of Two Human Milk Fortifiers in Preterm Infants

Evaluation of Human Milk Fortifiers in Preterm Infants

Sponsors

Lead sponsor: Abbott Nutrition

Source Abbott Nutrition
Brief Summary

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.

Overall Status Completed
Start Date December 2014
Completion Date February 2017
Primary Completion Date February 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Weight Gain Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Secondary Outcome
Measure Time Frame
Gastrointestinal Tolerance Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Length Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Head Circumference Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Enrollment 164
Condition
Intervention

Intervention type: Other

Intervention name: Human Milk Fortifier A

Description: Acidified concentrated liquid human milk fortifier

Arm group label: Study Human Milk Fortifier A

Intervention type: Other

Intervention name: Human Milk Fortifier B

Description: Non-acidified concentrated liquid human milk fortifier

Arm group label: Study Human Milk Fortifier B

Eligibility

Criteria:

Inclusion Criteria:

- Birth weight of 700 g-1500 g.

- ≤ 32 weeks and 0 days GA at birth.

- Appropriate for GA (AGA).

- Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).

- Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.

- Parent(s) agrees to allow infant to receive both human milk and HMF.

- Singleton or twin births only.

Exclusion Criteria:

- Enteral feeding of preterm infant formula or HMF for > 7 days.

- Expected to be transferred to another facility and will not be able to be followed for at least 15 days.

- Serious congenital abnormalities or underlying disease that may affect growth and development.

- 5 minute APGAR ≤ 4.

- Steroids used at the time of randomization.

- Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).

- Mechanical ventilator dependence.

- Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.

- Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).

- Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).

- Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).

- Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.

- Participation in another study that has not been approved as a concomitant study by AN.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bridget Barrett-Reis, PhD, RD Study Chair Abbott Nutrition
Location
facility
University of South Alabama Children's and Women's Hospital
Banner - University Medical Center Phoenix
Yale University
Medstar Georgetown University Hospital
South Miami Hospital
All Children's Hospital / Johns Hopkins
Memorial Hospital of South Bend
University of Louisville
Cohen Children's Medical Center of NY at North Shore
Cohen Children's Medical Center of NY
Duke University Medical Center
MetroHealth Medical Center
Lehigh Valley Health Network
Doctors Hospital at Renaissance/Women's Hospital at Renaissance
Cook Children's Medical Center
Texas Health and Education Institute
North Central Baptist Hospital
Wheaton Franciscan Heathcare Inc.- St. Joseph
Location Countries

United States

Verification Date

May 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Study Human Milk Fortifier A

Arm group type: Active Comparator

Description: Acidified processing method.

Arm group label: Study Human Milk Fortifier B

Arm group type: Experimental

Description: Non-acidified processing method.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov