Evaluation of Human Milk Fortifiers in Preterm Infants

Infant Growth Clinical Trial

Official title:

Evaluation of Two Human Milk Fortifiers in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307760
• Other study ID #: AL16
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: May 9, 2017
• Start date: December 2014
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infant Growth

Intervention

Other:
• Human Milk Fortifier A
Acidified concentrated liquid human milk fortifier
• Human Milk Fortifier B
Non-acidified concentrated liquid human milk fortifier

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Doctors Hospital at Renaissance/Women's Hospital at Renaissance	Edinburg	Texas
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Texas Health and Education Institute	Fort Worth	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Cohen Children's Medical Center of NY at North Shore	Manhasset	New York
United States	South Miami Hospital	Miami	Florida
United States	Wheaton Franciscan Heathcare Inc.- St. Joseph	Milwaukee	Wisconsin
United States	University of South Alabama Children's and Women's Hospital	Mobile	Alabama
United States	Yale University	New Haven	Connecticut
United States	Cohen Children's Medical Center of NY	New Hyde Park	New York
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona
United States	All Children's Hospital / Johns Hopkins	Saint Petersburg	Florida
United States	North Central Baptist Hospital	San Antonio	Texas
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Medstar Georgetown University Hospital	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain	scale measurement g/kg/d	Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Secondary	Gastrointestinal Tolerance	healthcare professional completed questionnaire	Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Secondary	Length	measured cm/wk	Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Secondary	Head Circumference	measured cm/wk	Study Day 1 to Study Day 29 (or discharge, whichever happens first)