Clinical trial NCT01373073: Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Official title: Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 147
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.


Eligibility criteria: Inclusion Criteria:

* 700-1500g birth weight
* 33 weeks or less gestational age
* Appropriate for gestational age
* Initiate enteral feeds of human milk by 21 days of life
* Mother provided exclusive human milk feeds
* Parents allow both human milk and study human milk fortifier
* Singleton or twin birth

Exclusion Criteria:

* Feeding preterm infant formula or non-study human milk fortifier
* Expected at facility less than 15 days
* Congenital anomalies/disease affecting growth and development
* 5 minute APGAR of 4 or less
* Steroid use
* ECMO
* Grade III or IV PVH/IVH
* Mechanical ventilator dependency
* Maternal incapacity
* History of major surgery
* Asphyxia
* Confirmed NEC or sepsis
* Use of probiotics

Primary outcomes:
measure: Weight gain
timeFrame: 29 days
Secondary outcomes:
measure: Anthropometric variables
timeFrame: 29 days
measure: GI tolerance
timeFrame: 29 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Tampa
country: United States
facility: University South Florida
state: Florida
city: Southbend
country: United States
facility: Memorial Hospital of Southbend
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Brooklyn
country: United States
facility: King's County Hospital Center
state: New York
city: Manhasset
country: United States
facility: Cohen Children's Medical Center of New York at North Shore
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of NY at North Shore
state: New York
city: Valhalla
country: United States
facility: Childrens Hospital Westchester Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center Rainbow Babies & Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Abbott Nutrition
name: Bridget Barrett-Reis, PhD
role: STUDY_CHAIR
References:
citation: Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010.