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PUFA Supplementation in Premature Infants

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LCPUFA supplement
placebo
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature, Extremely Low Birth Weight Infants focused on measuring neonatal prematurity, infant, extremely low birth weight, fatty acids, polyunsaturated

Eligibility Criteria

undefined - 72 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lurie Children's Hospital of Chicago
  • Prentice Women's Hospital
  • NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

"high" dose LCPUFA

"low" dose LCPUFA

placebo

Arm Description

the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.

the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.

the "placebo" is a drop that will be administered to ELBW infants.

Outcomes

Primary Outcome Measures

Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Secondary Outcome Measures

LCPUFA Levels
LCPUFA levels will be measured at 8 weeks of life.

Full Information

First Posted
September 27, 2013
Last Updated
August 13, 2021
Sponsor
NorthShore University HealthSystem
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Mead Johnson Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01955044
Brief Title
PUFA Supplementation in Premature Infants
Official Title
Early DHA Supplementation in Extremely Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Mead Johnson Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
Keywords
neonatal prematurity, infant, extremely low birth weight, fatty acids, polyunsaturated

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"high" dose LCPUFA
Arm Type
Experimental
Arm Description
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Arm Title
"low" dose LCPUFA
Arm Type
Experimental
Arm Description
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
the "placebo" is a drop that will be administered to ELBW infants.
Intervention Type
Dietary Supplement
Intervention Name(s)
LCPUFA supplement
Other Intervention Name(s)
PUFA supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
Description
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
Time Frame
2 weeks of life
Secondary Outcome Measure Information:
Title
LCPUFA Levels
Description
LCPUFA levels will be measured at 8 weeks of life.
Time Frame
8 weeks of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Caplan, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27356083
Citation
Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3.
Results Reference
derived

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PUFA Supplementation in Premature Infants

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