Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Preterm Infants Clinical Trial

Official title:

Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373073
• Other study ID #: AK37
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2011
• Last updated: February 19, 2013
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Other:
• Experimental human milk fortifier
Human milk fortifier to be added to human milk feedings
• Control human milk fortifier
Control human milk fortifier to be added to human milk

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Alabama	Birmingham	Alabama
United States	King's County Hospital Center	Brooklyn	New York
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospitals Case Medical Center Rainbow Babies & Children's Hospital	Cleveland	Ohio
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	OHSU	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	UCSD Medical Center	San Diego	California
United States	Memorial Hospital of Southbend	Southbend	Indiana
United States	University South Florida	Tampa	Florida
United States	Toledo Children's Hospital	Toledo	Ohio
United States	Childrens Hospital Westchester Medical Center	Valhalla	New York
United States	Wesley Medical Center	Wichita	Kansas

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		29 days	No
Secondary	Anthropometric variables	Length and head circumference	29 days	No
Secondary	GI tolerance	stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.	29 days	No