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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02307760
Other study ID # AL16
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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