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Completed

NCT Number: NCT00760942

Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.

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Key information

Conditions

Infant, Very Low Birth Weight Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit/Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants between 500 and 1499 grams of birthweight, receiving mother's milk.

Exclusion criteria

  • Infants with major congenital anomalies and previous history of gastrointestinal disease.

Treatment and study plan

Similac special care 30

Dietary Supplement

Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.

Similac human milk fortifier

Dietary Supplement

Powdered human milk fortifier.

Primary outcomes

  1. The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.

    Time frame: 2 - 6 weeks

Secondary outcomes

  1. Hospital stay and feeding intolerance

    Time frame: 2-6 weeks

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2008
Registry last updated
Dec 10, 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.

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