Table 2.
Change in outcomes from baseline to trial end, Preemie Tots trial (n = 31), 2012–2015.
| |
Baseline |
Trial end |
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Measure | N (Omega 3-6-9/ placebo) |
Omega 3-6- 9 |
Placebo | N (Omega 3-6-9/ placebo) |
Omega 3-6- 9 |
Placebo | Difference in change (95% CI)a |
Effect size (d) |
p- value |
| Child Behavior Checklist (CBCL) | |||||||||
| Higher scores = more behavior indicative of domain | |||||||||
| Syndrome scales | |||||||||
| Emotionally reactive | 15/16 | 3.73 (3.35) | 2.56 (2.19) | 12/16 | 2.42 (1.98) | 2.69 (3.22) | −1.46 (−3.01, 0.09) | −0.64 | 0.06 |
| Anxious/depressed | 15/16 | 3.40 (3.29) | 3.38 (2.68) | 12/16 | 2.42 (1.98) | 3.38 (2.39) | −1.27 (2.53, 0.00) | −0.58 | 0.049 |
| Somatic complaints | 15/16 | 2.73 (3.83) | 1.81 (2.32) | 12/16 | 1.58 (1.56) | 1.75 (2.54) | 0.53 (−1.49, 0.43) | −0.35 | 0.27 |
| Withdrawn | 15/16 | 2.80 (2.60) | 3.81 (3.12) | 12/16 | 2.42 (2.87) | 3.06 (2.77) | 0.36 (−0.88, 1.59) | 0.08 | 0.56 |
| Sleep problems | 15/16 | 3.53 (3.80) | 3.50 (3.50) | 12/16 | 3.17 (3.81) | 2.88 (2.53) | 0.57 (−1.02, 2.15) | 0.24 | 0.47 |
| Attention problems | 15/16 | 4.20 (2.68) | 4.38 (2.03) | 12/16 | 3.67 (3.08) | 4.06 (1.81) | −0.08 (−1.45, 1.29) | −0.15 | 0.91 |
| Aggressive behavior | 15/16 | 13.60 (9.79) | 13.75 (7.68) | 12/16 | 10.58 (8.67) | 11.38 (7.46) | −0.31 (−4.19, 3.56) | −0.05 | 0.87 |
| Problem scales | |||||||||
| Internalizing | 15/16 | 12.67 (10.24) | 11.56 (8.34) | 12/16 | 8.83 (7.04) | 10.69 (8.67) | −3.41 (−6.87, 0.06) | −0.68 | 0.05 |
| Externalizing | 15/16 | 17.80 (11.83) | 18.13 (8.66) | 12/16 | 14.25 (10.26) | 15.44 (8.29) | −0.35 (−4.58, 3.88) | −0.05 | 0.87 |
| Total problems | 15/16 | 48.67 (32.05) | 46.63 (21.61) | 12/16 | 37.92 (29.14) | 42.50 (22.64) | −5.42 (−16.44, 5.61) | −0.34 | 0.32 |
| Stress problems | 15/16 | 2.40 (2.20) | 1.94 (1.84) | 12/16 | 1.83 (1.85) | 2.06 (1.77) | −0.64 (1.63, 0.35) | −0.42 | 0.20 |
| DSM-oriented Scales | |||||||||
| Affective problems | 15/16 | 3.07 (3.24) | 2.75 (2.56) | 12/16 | 2.75 (2.96) | 2.56 (3.12) | −0.14 (−1.50, 1.22) | −0.05 | 0.83 |
| Anxiety problems | 15/16 | 4.40 (3.44) | 3.94 (2.72) | 12/16 | 3.67 (2.99) | 4.00 (2.13) | −0.74 (−1.96, 0.49) | −0.37 | 0.23 |
| Pervasive developmental problems | 15/16 | 5.87 (5.10) | 6.44 (3.81) | 12/16 | 4.58 (4.40) | 5.25 (4.11) | −0.39 (−2.68, 1.89) | −0.14 | 0.73 |
| Attention deficit/hyperactivity problems | 15/16 | 6.13 (3.74) | 6.94 (2.52) | 12/16 | 4.92 (4.19) | 5.94 (2.64) | −0.17 (2.09, 1.75) | −0.07 | 0.86 |
| Oppositional defiant problems | 15/16 | 4.00 (3.44) | 4.44 (3.18) | 12/16 | 3.50 (3.63) | 3.50 (2.99) | 0.35 (−1.2, 2.21) | 0.13 | 0.71 |
| Toddler Behavior Assessment Questionnaire – Short Form (TBAQ-SF) | |||||||||
| Higher scores = more behavior indicative of domain | |||||||||
| Activity level | 15/16 | 4.96 (0.94) | 4.08 (0.97) | 13/15 | 4.69 (1.93) | 4.08 (1.03) | −0.11 (−0.57, 0.36) | −0.24 | 0.64 |
| Anger | 15/16 | 4.42 (1.45) | 4.17 (0.86) | 13/15 | 4.18 (1.00) | 4.24 (1.04) | −0.13 (−0.78, 0.53) | −0.11 | 0.70 |
| Inhibitory control | 15/16 | 3.32 (1.25) | 3.84 (1.13) | 13/15 | 3.67 (0.90) | 3.80 (0.91) | 0.07 (−0.58, 0.7) | 0.04 | 0.83 |
| Interest | 15/16 | 3.86 (0.76) | 4.00 (0.74) | 13/15 | 3.96 (0.93) | 4.07 (0.72) | −0.02 (−0.44, 0.41) | −0.03 | 0.94 |
| Pleasure | 15/16 | 4.58 (1.16) | 4.05 (1.00) | 13/15 | 5.22 (0.78) | 4.20 (1.22) | 0.46 (−0.08, 1.01) | 0.68 | 0.09 |
| Social fearfulness | 15/16 | 3.95 (1.44) | 4.52 (1.01) | 13/15 | 3.90 (1.22) | 4.77 (1.29) | −0.54 (−1.22, 0.15) | −0.63 | 0.12 |
| Vineland Adaptive Behavior Scales, 2nd Edition (VABS-2) | |||||||||
| Higher scores = more behavior indicative of domain | |||||||||
| Play and leisure time | 15/13 | 17.13 (8.26) | 17.92 (11.67) | 12/14 | 21.23 (8.50) | 19.57 (6.58) | 1.39 (−4.51, 7.29) | 0.20 | 0.63 |
| Interpersonal relationships | 15/15 | 29.07 (11.34) | 26.87 (9.66) | 13/15 | 37.23 (8.76) | 28.60 (7.66) | 7.50 (1.63, 13.67) | 0.83 | 0.01 |
| Coping skills | 15/13 | 8.33 (6.69) | 6.23 (3.24) | 13/14 | 9.83 (6.97) | 8.14 (5.49) | 1.11 (−2.38, 4.60) | 0.16 | 0.52 |
| Children's Sleep Habits Questionnaire (CSHQ) | |||||||||
| Higher scores = more disturbed sleep behavior in domain | |||||||||
| Daytime sleepiness | 15/16 | 1.48 (0.37) | 1.47 (0.26) | 12/15 | 1.46 (0.37) | 1.36 (0.26) | 0.06 (−0.13, 0.25) | 0.22 | 0.55 |
| Night wakings | 15/16 | 1.56 (0.54) | 1.65 (0.46) | 12/15 | 1.53 (0.59) | 1.44 (0.41) | 0.23 (−0.04, 0.51) | 0.59 | 0.09 |
| Bedtime resistance | 15/16 | 1.61 (0.71) | 1.69 (0.57) | 12/15 | 1.46 (0.52) | 1.61 (0.58) | −0.02 (−0.31, 0.28) | −0.08 | 0.91 |
| Parasomnias | 15/16 | 1.32 (0.22) | 1.48 (0.32) | 12/15 | 1.33 (0.19) | 1.32 (0.17) | 0.07 (−0.05, 0.19) | 0.29 | 0.25 |
| Sleep anxiety | 15/16 | 1.52 (0.51) | 1.61 (0.44) | 12/15 | 1.52 (0.57) | 1.42 (0.40) | 0.18 (−0.11, 0.46) | 0.41 | 0.22 |
| Sleep onset delayb | 15/16 | 1.60 (0.21) | 1.81 (0.91) | 12/15 | 1.75 (0.97) | 1.73 (0.88) | 0.27 (−0.21, 0.75) | 0.43 | 0.26 |
| Sleep disordered breathing | 15/16 | 1.16 (0.21) | 1.29 (0.36) | 12/15 | 1.13 (0.24) | 1.18 (0.31) | −0.02 (−0.20, 0.17) | −0.08 | 0.87 |
| Sleep duration | 15/16 | 1.38 (0.64) | 1.40 (0.60) | 12/15 | 1.33 (0.57) | 1.13 (0.25) | 0.16 (−0.06, 0.38) | 0.53 | 0.14 |
| Total score | 15/16 | 1.47 (0.26) | 1.54 (0.28) | 12/15 | 1.43 (0.28) | 1.40 (0.16) | 0.07 (−0.05, 0.18) | 0.38 | 0.25 |
| Brief Infant Sleep Questionnaire (BISQ, minutes) | |||||||||
| Higher scores = more time spent in domain | |||||||||
| Nocturnal sleep duration | 15/16 | 518.07 (121.62) | 545.63 (88.47) | 12/15 | 541.25 (118.02) | 540.00 (57.82) | 16.51 (−26.83, 59.85) | 0.26 | 0.44 |
| Daytime sleep duration | 15/16 | 116.47 (100.92) | 148.13 (82.32) | 12/15 | 130.00 (59.08) | 149.07 (117.61) | −18.59 (−79.99, 42.80) | −0.10 | 0.54 |
| Total sleep duration | 15/16 | 634.53 (151.84) | 693.75 (102.69) | 12/15 | 671.25 (95.11) | 689.07 (147.44) | −9.92 (−93.14, 73.21) | −0.03 | 0.81 |
| Sleep onset duration | 15/16 | 29.47 (30.44) | 38.63 (25.08) | 12/15 | 27.50 (23.98) | 31.93 (33.09) | 6.53 (−15.98, 29.05) | 0.07 | 0.56 |
| Night wakefulness | 15/16 | 39.67 (74.89) | 64.06 (62.24) | 12/15 | 38.33 (53.24) | 27.47 (42.92) | 23.37 (−8.60, 55.34) | 0.39 | 0.15 |
a
Difference in change column is based on mixed effects model (analogous to ANCOVA) using maximum likelihood to account for missing data and thus may differ from the results of the raw summary statistics for the within-group mean change.
b
The variance of this model with the random effect for the family unit within the mixed model was estimated to be zero; therefore, effect for the family unit was removed from the model.