Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Phase 3

Completed

• Conditions: Preterm Infants
• Interventions: Other: Experimental human milk fortifier; Other: Control human milk fortifier

• Registration Number: NCT01373073
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Human Milk Fortifier	Experimental human milk fortifier	Experimental human milk fortifier to be added to human milk
Control Human Milk Fortifier	Control human milk fortifier	Control human milk fortifier to be added to human milk

Primary Outcome Measures

Name	Time	Method
Weight gain	29 days

Secondary Outcome Measures

Name	Time	Method
Anthropometric variables	29 days	Length and head circumference
GI tolerance	29 days	stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.

Trial Locations

Locations (15)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University South Florida; 🇺🇸 Tampa, Florida, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Memorial Hospital of Southbend; 🇺🇸 Southbend, Indiana, United States

King's County Hospital Center; 🇺🇸 Brooklyn, New York, United States

Wesley Medical Center; 🇺🇸 Wichita, Kansas, United States

Cohen Children's Medical Center of New York at North Shore; 🇺🇸 Manhasset, New York, United States

Cohen Children's Medical Center of NY at North Shore; 🇺🇸 New Hyde Park, New York, United States

Childrens Hospital Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Toledo Children's Hospital; 🇺🇸 Toledo, Ohio, United States

OHSU; 🇺🇸 Portland, Oregon, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

University Hospitals Case Medical Center Rainbow Babies & Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States