Skip to main content
OpenTrials
Completed

NCT Number: NCT01373073

Evaluation of a Novel Human Milk Fortifier in Preterm Infants

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Infants

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental human milk fortifier

Other

Human milk fortifier to be added to human milk feedings

Control human milk fortifier

Other

Control human milk fortifier to be added to human milk

Primary outcomes

  1. Weight gain

    Time frame: 29 days

Secondary outcomes

  1. Anthropometric variables

    Time frame: 29 days

    Length and head circumference

  2. GI tolerance

    Time frame: 29 days

    stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc.

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2011
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.