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OpenTrials
Completed

NCT Number: NCT03192839

Early DHA Supplementation in Very Low Birth Weight Infants

This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center, Chicago, Illinois, 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

  • Very low birth weight infants weighing less than 1500 grams
  • Consent signed within 72 hours of life

Exclusion criteria

  • Infants with know metabolic disorder
  • Infants with known congenital GI anomaly
  • Infants who are deemed to be inappropriate for enrollment per attending neonatologist

Treatment and study plan

Low dose PUFA

Other

Low dose PUFA

High dose PUFA

Other

High dose PUFA

Placebo

Other

Placebo

Primary outcomes

  1. Red Blood Cell polyunsaturated fatty acids (PUFA) levels

    Time frame: 2 weeks of age

Secondary outcomes

  1. Red Blood Cell PUFA levels

    Time frame: 8 weeks of age

  2. Feeding tolerance

    Time frame: 8 weeks

    Full enteral feed of 120 kcal/kg/day

  3. Incidence of necrotizing enterocolitis

    Time frame: 8 weeks

  4. Incidence of bronchopulmonary dysplasia

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • North Shore Research Institue

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
May 7, 2019

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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