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Completed

NCT Number: NCT01955044

PUFA Supplementation in Premature Infants

The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.

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Key information

Conditions

Premature, Extremely Low Birth Weight Infants Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Polyunsaturated Fatty Acid Levels Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

Loading trial locations.

About this study

This will be a multi-center, randomized, placebo controlled, double blind trial.

Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.

ELBW infants will be enrolled into this study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • a) Premature infant born at gestational age less than 34 weeks
  • b) Birth weight less than 1000 grams
  • c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures

Exclusion criteria

  • a) infants with known metabolic disorder
  • b) infants with known congenital gastrointestinal anomaly
  • c) infants who are deemed to be inappropriate for enrollment per attending neonatologist

Treatment and study plan

LCPUFA Supplement

Dietary Supplement

Other names: PUFA supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels

    Time frame: 2 weeks of life

    LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Secondary outcomes

  1. LCPUFA Levels

    Time frame: 8 weeks of life

    LCPUFA levels will be measured at 8 weeks of life.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Mead Johnson Nutrition
  • Northwestern University

Registry information

Official study title

Early DHA Supplementation in Extremely Low Birth Weight Infants

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 7, 2013
Registry last updated
Sep 5, 2021

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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