Clinical trial NCT02307760: Evaluation of Human Milk Fortifiers in Preterm Infants
Official title: Evaluation of Two Human Milk Fortifiers in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Growth
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Weight Gain
timeFrame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
measure: Length
timeFrame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
measure: Head Circumference
timeFrame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Children's and Women's Hospital
state: Alabama
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington, D.C.
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: All Children's Hospital / Johns Hopkins
state: Florida
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Manhasset
country: United States
facility: Cohen Children's Medical Center of NY at North Shore
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of NY
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance/Women's Hospital at Renaissance
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Health and Education Institute
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
city: Milwaukee
country: United States
facility: Wheaton Franciscan Heathcare Inc.- St. Joseph
state: Wisconsin
Study officials:
affiliation: Abbott Nutrition
name: Bridget Barrett-Reis, PhD, RD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.