PUFA Supplementation in Premature Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early DHA Supplementation in Extremely Low Birth Weight Infants

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

Intervention / Treatment
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* Dietary Supplement: LCPUFA supplement
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose LCPUFA<br>the high dose LCPUFA supplement is a drop that will be administered to ELBW infants. | Dietary Supplement: LCPUFA supplement<br> <br> * Other names: PUFA supplement;|
| Experimental: low dose LCPUFA<br>the low dose LCPUFA supplement is a drop that will be administered to ELBW infants. | Dietary Supplement: LCPUFA supplement<br> <br> * Other names: PUFA supplement;|
| Placebo Comparator: placebo<br>the placebo is a drop that will be administered to ELBW infants. | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCPUFA Levels | LCPUFA levels will be measured at 8 weeks of life. | 8 weeks of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal prematurity, infant, extremely low birth weight, fatty acids, polyunsaturated