Trial Outcomes & Findings for PUFA Supplementation in Premature Infants (NCT NCT01955044)

NCT ID: NCT01955044

Last Updated: 2021-09-05

Results Overview

LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 2 weeks of life
• Results posted on: 2021-09-05

Participant Flow

Participant milestones

Measure	"High" Dose LCPUFA the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	"Low" Dose LCPUFA the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	Placebo the "placebo" is a drop that will be administered to ELBW infants. placebo
Overall Study STARTED	10	10	10
Overall Study COMPLETED	9	9	10
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	"High" Dose LCPUFA the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	"Low" Dose LCPUFA the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	Placebo the "placebo" is a drop that will be administered to ELBW infants. placebo
Overall Study Death	1	1	0

Baseline Characteristics

PUFA Supplementation in Premature Infants

Baseline characteristics by cohort

Measure	"High" Dose LCPUFA n=10 Participants the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	"Low" Dose LCPUFA n=10 Participants the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	Placebo n=10 Participants the "placebo" is a drop that will be administered to ELBW infants. placebo	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 weeks of life

Population: 2 subjects died prior to having 2 week levels drawn, from causes unrelated to study.

LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Outcome measures

Measure	"High" Dose LCPUFA n=9 Participants the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	"Low" Dose LCPUFA n=9 Participants the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	Placebo n=10 Participants the "placebo" is a drop that will be administered to ELBW infants. placebo
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels 2 week ARA (arachidonic acid) levels	20.3 weight % (g/100g) Interval 18.91 to 21.34	19.3 weight % (g/100g) Interval 17.64 to 22.54	21.58 weight % (g/100g) Interval 20.2 to 23.04
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels 2 week DHA levels	4.45 weight % (g/100g) Interval 4.36 to 5.16	4.02 weight % (g/100g) Interval 3.96 to 4.77	5.27 weight % (g/100g) Interval 4.75 to 5.63

SECONDARY outcome

Timeframe: 8 weeks of life

Population: 2 subjects died prior to having 8 week levels drawn, from causes unrelated to study.

LCPUFA levels will be measured at 8 weeks of life.

Outcome measures

Measure	"High" Dose LCPUFA n=9 Participants the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	"Low" Dose LCPUFA n=9 Participants the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	Placebo n=10 Participants the "placebo" is a drop that will be administered to ELBW infants. placebo
LCPUFA Levels 8 week DHA levels	5.52 wt% (g/100g) Interval 4.45 to 7.08	5.58 wt% (g/100g) Interval 5.49 to 6.96	6.75 wt% (g/100g) Interval 5.22 to 7.4
LCPUFA Levels 8 week ARA levels	19.79 wt% (g/100g) Interval 17.77 to 22.99	19.9 wt% (g/100g) Interval 18.3 to 21.06	22.21 wt% (g/100g) Interval 19.05 to 23.11

Adverse Events

"High" Dose LCPUFA

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

"Low" Dose LCPUFA

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	"High" Dose LCPUFA n=10 participants at risk the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	"Low" Dose LCPUFA n=10 participants at risk the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	Placebo n=10 participants at risk the "placebo" is a drop that will be administered to ELBW infants. placebo
Gastrointestinal disorders death	0.00% 0/10	10.0% 1/10 • Number of events 1	0.00% 0/10
Respiratory, thoracic and mediastinal disorders death	10.0% 1/10 • Number of events 1	0.00% 0/10	0.00% 0/10
Gastrointestinal disorders spontaneous bowel perforation	0.00% 0/10	10.0% 1/10 • Number of events 1	0.00% 0/10

Other adverse events

Adverse event data not reported

Additional Information

Brandy L Frost

NorthShore University HealthSystem

Phone: 847-570-2033

Email: bfrost@northshore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place