Adults 10 Months to 16 Months, any sex, with Preterm Birth or Child Development. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Erythrocyte Fatty Acid LevelsPrimary· Baseline to 180 days post-randomization
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Linoleic acid (18:2n-6)
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-2.1
± 5.2
Placebo
0.6
± 4.4
Arachidonic acid (20:4n-6)
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
2.0
± 2.6
Placebo
-0.2
± 1.1
Total n-6
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.2
± 6.0
Placebo
0.4
± 5.0
α-linolenic acid (18:3n-3)
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.1
± 0.4
Placebo
0.0
± 0.3
Eicosapentaenoic acid (20:5n-3)
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.0
± 0.1
Placebo
-0.1
± 0.2
Docosapentaenoic acid (22:5n-3)
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.1
± 0.1
Placebo
0.0
± 0.1
Docosahexaenoic acid (22:6n-3)
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
1.1
± 1.0
Placebo
-0.1
± 0.2
Total n-3
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.9
± 1.1
Placebo
-0.2
± 0.5
Erythrocyte Fatty Acid Levels (Additional Data)Primary· Baseline to 180 days post-randomization
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-3.2
± 3.9
Placebo
1.6
± 2.8
Enrollment and Trial CompletionPrimary· Baseline to 180 days post-randomization
The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.
Study Visit 2 Completion
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
172
Placebo
163
Study Visit 3 Completion
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
166
Placebo
168
AdherencePrimary· Baseline to 180 days post-randomization
The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
80.6
± 28
Placebo
80.7
± 25
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)Secondary· Baseline to 180 days post-randomization
Infant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline).
Effortful Control
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.7
± 0.8
Placebo
-0.5
± 0.8
Activity Level
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.6
± 1.5
Placebo
0.5
± 1.5
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)Secondary· Baseline to 180 days post-randomization
Bayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and t
Cognitive Composite
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-2.6
± 13.3
Placebo
-3.7
± 12.2
Language Composite
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.5
± 12.0
Placebo
0.2
± 12.6
Motor Composite
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.6
± 12.5
Placebo
-0.4
± 12.7
Brief Infant Sleep Questionnaire (BISQ)Secondary· Baseline to 180 days post-randomization
The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the BISQ value at 180 days minus the BISQ value at baseline).
Nocturnal Sleep Duration
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.25
± 1.61
Placebo
-0.16
± 1.34
Daytime Sleep Duration
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.32
± 1.15
Placebo
-0.46
± 1.25
Total Sleep Duration
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.07
± 2.22
Placebo
-0.57
± 1.7
Body CompositionSecondary· Baseline to 180 days post-randomization
Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds). These measurements were converted to z scores for corrected age based on Child Growth Standards from the World Health Organization. The z-score indicates the number of standard deviations away from the mean. A z score of 0 is equal to the mean of a reference population (children the same age and sex). Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate val
Weight
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.1
± 0.4
Placebo
0.0
± 0.4
Recumbent Length
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.1
± 0.9
Placebo
0.2
± 0.9
Head Circumference
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.0
± 0.6
Placebo
-0.1
± 0.5
Mid-Upper Arm Circumference
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
0.0
± 0.8
Placebo
0.1
± 0.7
Triceps Skinfold
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.0
± 0.7
Placebo
-0.1
± 0.8
Subscapular Skinfold
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.2
± 0.8
Placebo
-0.2
± 0.9
Brief Infant Toddler Social Emotional Assessment (BITSEA)Secondary· 180 days post-randomization
BITSEA measures socioemotional development in toddlerhood. Scores were summed to provide competence (range: 0-22) and problem (range: 0-62) scores, respectively. The problem scale is further divided into subscales: externalizing (6 items; range: 0-12), internalizing (8 items; range: 0-16), and dysregulation (8 items; range: 0-16). Additionally, 14 items comprise a red flag scale (range: 0-28). Eight items from the competence and nine items from the problem subscales are indicative of behaviors often seen in children with ASD. Each of the 17 ASD items was dichotomized to illustrate the presence
Competence
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
16.50
± 3.09
Placebo
16.73
± 2.94
Problem
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
9.81
± 6.01
Placebo
10.18
± 6.84
Externalizing
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
2.29
± 2.06
Placebo
2.30
± 1.98
Internalizing
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
2.04
± 1.58
Placebo
2.31
± 2.10
Dysregulation
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
3.25
± 2.57
Placebo
3.29
± 2.59
Red Flag
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
2.93
± 2.48
Placebo
3.12
± 2.85
ASD
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
4.11
± 2.29
Placebo
4.36
± 2.98
Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II)Secondary· 180 days post-randomization
The PDDST-II is a clinically derived, caregiver-completed screener to assist in differentiating an ASD diagnosis from other disorders in children with developmental concerns, including those born preterm. The PDDST-II comprised 14 yes/no items that indicate the presence (1) or absence (0) of developmental concerns. Items were summed (possible range: 0-14) and higher scores represented greater developmental concern.
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
2.91
± 2.35
Placebo
3.37
± 3.02
Other Long-term Outcomes: Sleep (BISQ)Secondary· Long-term effect (approximately 8 months) after intervention completion
Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at post-intervention follow-up (approximately 8 months after the trial ended). The scores were calculated as a change between two time points (the BISQ value at p
Nocturnal Sleep Duration
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.11
± 1.68
Placebo
-0.38
± 1.43
Daytime Sleep Duration
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.46
± 1.30
Placebo
-0.81
± 1.41
Total Sleep Duration
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
-0.57
± 2.20
Placebo
-1.17
± 1.85
Other Long-term Outcomes: Sleep (CSHQ)Secondary· Long-term effect (approximately 8 months) after intervention completion
Long-term (26-32 months of age) outcomes. This will be evaluated using the total score on a subset of 13 items from the Children's Sleep Habits Questionnaire (CSHQ). The range in total score is 13-39. A higher score is indicative of more sleep problems.
Group
Value
95% CI
Docosahexaenoic Acid + Arachidonic Acid
18.82
± 4.96
Placebo
19.57
± 5.40
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to 180 days post randomization.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sarah Keim
Last refreshed: 29 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01576783.