Evaluation of Human Milk Fortifiers in Preterm Infants

NCT02307760 | Completed

• 1 other identifier: AL16
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 18

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.

Conditions

Infant Growth

Outcome Measures

Primary Outcomes (1)

• Weight Gain

  scale measurement g/kg/d

  Study Day 1 to Study Day 29 (or discharge, whichever happens first)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Study Human Milk Fortifier A

ACTIVE COMPARATOR

Acidified processing method.

Other: Human Milk Fortifier A

Study Human Milk Fortifier B

EXPERIMENTAL

Non-acidified processing method.

Other: Human Milk Fortifier B

Interventions

Human Milk Fortifier A OTHER

Acidified concentrated liquid human milk fortifier

Study Human Milk Fortifier A

Human Milk Fortifier B OTHER

Non-acidified concentrated liquid human milk fortifier

Study Human Milk Fortifier B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (18)

University of South Alabama Children's and Women's Hospital

Mobile, Alabama, 36604, United States

Location

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85014, United States

Location

Yale University

New Haven, Connecticut, 06520-8064, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

South Miami Hospital

Miami, Florida, 33143, United States

Location

All Children's Hospital / Johns Hopkins

St. Petersburg, Florida, 33701, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Cohen Children's Medical Center of NY at North Shore

Manhasset, New York, 11030, United States

Location

Cohen Children's Medical Center of NY

New Hyde Park, New York, 11040, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Doctors Hospital at Renaissance/Women's Hospital at Renaissance

Edinburg, Texas, 78539, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Texas Health and Education Institute

Fort Worth, Texas, 76104, United States

Location

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

Location

Wheaton Franciscan Heathcare Inc.- St. Joseph

Milwaukee, Wisconsin, 53210, United States

Location

Related Publications (2)

• Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y.

  PMID: 31975350 DERIVED

• Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5.

  PMID: 30195561 DERIVED

Study Officials

• Bridget Barrett-Reis, PhD, RD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (18)