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PUFA Supplementation in Premature Infants

Early DHA Supplementation in Extremely Low Birth Weight Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01955044
Enrollment
30
Registered
2013-10-07
Start date
2013-09-30
Completion date
2016-04-30
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

neonatal prematurity, infant, extremely low birth weight, fatty acids, polyunsaturated

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.

Interventions

DIETARY_SUPPLEMENTLCPUFA supplement
DIETARY_SUPPLEMENTplacebo

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
CollaboratorOTHER
Northwestern University Feinberg School of Medicine
CollaboratorOTHER
Mead Johnson Nutrition
CollaboratorINDUSTRY
Endeavor Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 weeks of lifeLCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Secondary

MeasureTime frameDescription
LCPUFA Levels8 weeks of lifeLCPUFA levels will be measured at 8 weeks of life.

Countries

United States

Participant flow

Participants by arm

ArmCount
High Dose LCPUFA
the high dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement
10
Low Dose LCPUFA
the low dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement
10
Placebo
the placebo is a drop that will be administered to ELBW infants. placebo
10
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath110

Baseline characteristics

CharacteristicHigh Dose LCPUFALow Dose LCPUFAPlaceboTotal
Age, Categorical
<=18 years
10 Participants10 Participants10 Participants30 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
10 participants10 participants10 participants30 participants
Sex: Female, Male
Female
2 Participants5 Participants4 Participants11 Participants
Sex: Female, Male
Male
8 Participants5 Participants6 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 100 / 100 / 10
serious
Total, serious adverse events
1 / 101 / 100 / 10

Outcome results

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

Time frame: 2 weeks of life

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

ArmMeasureGroupValue (MEDIAN)
High Dose LCPUFALong-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 week DHA levels4.45 weight % (g/100g)
High Dose LCPUFALong-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 week ARA (arachidonic acid) levels20.3 weight % (g/100g)
Low Dose LCPUFALong-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 week DHA levels4.02 weight % (g/100g)
Low Dose LCPUFALong-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 week ARA (arachidonic acid) levels19.3 weight % (g/100g)
PlaceboLong-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 week DHA levels5.27 weight % (g/100g)
PlaceboLong-chain Polyunsaturated Fatty Acid (LCPUFA) Levels2 week ARA (arachidonic acid) levels21.58 weight % (g/100g)
Secondary

LCPUFA Levels

LCPUFA levels will be measured at 8 weeks of life.

Time frame: 8 weeks of life

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

ArmMeasureGroupValue (MEDIAN)
High Dose LCPUFALCPUFA Levels8 week DHA levels5.52 wt% (g/100g)
High Dose LCPUFALCPUFA Levels8 week ARA levels19.79 wt% (g/100g)
Low Dose LCPUFALCPUFA Levels8 week DHA levels5.58 wt% (g/100g)
Low Dose LCPUFALCPUFA Levels8 week ARA levels19.9 wt% (g/100g)
PlaceboLCPUFA Levels8 week DHA levels6.75 wt% (g/100g)
PlaceboLCPUFA Levels8 week ARA levels22.21 wt% (g/100g)
Comparison: DHA levelsp-value: 0.05Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026