PUFA Supplementation in Premature Infants

Polyunsaturated Fatty Acid Levels Clinical Trial

Official title:

Early DHA Supplementation in Extremely Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955044
• Other study ID #: EH13-334
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2021
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Polyunsaturated Fatty Acid Levels
• Premature Birth
• Premature, Extremely Low Birth Weight Infants

Intervention

Dietary Supplement:
• LCPUFA supplement

• placebo

Locations

Country	Name	City	State
United States	Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Prentice Women's Hospital	Chicago	Illinois
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Ann & Robert H Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels	LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants	2 weeks of life
Secondary	LCPUFA Levels	LCPUFA levels will be measured at 8 weeks of life.	8 weeks of life