An interventional study of LCPUFA supplement and placebo in Premature, Extremely Low Birth Weight Infants and Polyunsaturated Fatty Acid Levels, sponsored by Endeavor Health. Completed at 3 sites in United States. Open to participants aged Up to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Endeavor Health · Not applicable, Interventional, and Prevention
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Endeavor Health is the lead sponsor of 110 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Dietary Supplement: LCPUFA supplement
the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.
Dietary Supplement: LCPUFA supplement
the "placebo" is a drop that will be administered to ELBW infants.
Dietary Supplement: placebo
Also known as: PUFA supplement
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
Time frame: 2 weeks of life
LCPUFA Levels
LCPUFA levels will be measured at 8 weeks of life.
Time frame: 8 weeks of life
| Milestone | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 9 | 9 | 10 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Death | 1 | 1 | 0 |
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
| weight % (g/100g) | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo |
|---|---|---|---|
| 2 week DHA levels | 4.45 (4.36 to 5.16) | 4.02 (3.96 to 4.77) | 5.27 (4.75 to 5.63) |
| 2 week ARA (arachidonic acid) levels | 20.3 (18.91 to 21.34) | 19.3 (17.64 to 22.54) | 21.58 (20.2 to 23.04) |
LCPUFA levels will be measured at 8 weeks of life.
| wt% (g/100g) | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo |
|---|---|---|---|
| 8 week DHA levels | 5.52 (4.45 to 7.08) | 5.58 (5.49 to 6.96) | 6.75 (5.22 to 7.4) |
| 8 week ARA levels | 19.79 (17.77 to 22.99) | 19.9 (18.3 to 21.06) | 22.21 (19.05 to 23.11) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| "High" Dose LCPUFA | — | 1/10 (10%) | 0/10 (0%) |
| "Low" Dose LCPUFA | — | 1/10 (10%) | 0/10 (0%) |
| Placebo | — | 0/10 (0%) | 0/10 (0%) |
| Event | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo |
|---|---|---|---|
| deathGastrointestinal disorders | 0/10 | 1/10 | 0/10 |
| deathRespiratory, thoracic and mediastinal disorders | 1/10 | 0/10 | 0/10 |
| spontaneous bowel perforationGastrointestinal disorders | 0/10 | 1/10 | 0/10 |
| Age, Categorical(Participants) | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 10 | 10 | 10 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo | Total |
|---|---|---|---|---|
| Female | 2 | 5 | 4 | 11 |
| Male | 8 | 5 | 6 | 19 |
| Region of Enrollment(participants) | "High" Dose LCPUFA | "Low" Dose LCPUFA | Placebo | Total |
|---|---|---|---|---|
| United States | 10 | 10 | 10 | 30 |
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Endeavor Health