Secondary outcomes, hospital admission and growth measurements at follow-up
Dopamine (n=20)* | Placebo (n=19)* | ||||
Bayley-3 | |||||
Scores | Mean (SD) | Mean (SD) | Δ | (95% CI)† | P value† |
Cognitive‡ | 89.5 (18.1) | 84.3 (19.9) | 5.1 | (−6.8 to 17.1) | 0.398 |
Language§ | 85.2 (21.6) | 82.3 (20.6) | 2.9 | (−10.7 to 16.5) | 0.675 |
Motor‡ | 86.5 (21.0) | 82.9 (19.9) | 0.9 | (−10.1 to 11.9) | 0.874 |
Impairment | n (%) | n (%) | OR | (95% CI)¶ | P value¶ |
Cognitive‡ | 6 (32) | 8 (44) | 0.54 | (0.13 to 2.31) | 0.409 |
Moderate | 3 | 3 | |||
Severe | 3 | 5 | |||
Language§ | 6 (35) | 8 (44) | 0.67 | (0.16 to 2.70) | 0.569 |
Moderate | 1 | 3 | |||
Severe | 5 | 5 | |||
Motor‡ | 7 (37) | 9 (50) | 0.64 | (0.14 to 2.79) | 0.549 |
Moderate | 3 | 6 | |||
Severe | 4 | 3 | |||
Components of impairment | n (%) | n (%) | OR | (95% CI)¶ | P value¶ |
CP | 4 (20) | 3 (16) | 1.73 | (0.27 to 10.96) | 0.563 |
CP severity | |||||
Moderate | 3 | 1 | |||
Severe | 1 | 2 | |||
Type of CP | |||||
Spastic unilateral | 1 | 0 | |||
Spastic bilateral | 2 | 3 | |||
Other | 1 | 0 | |||
Hearing impairment** | 3 (16) | 0 (0) | |||
Severe | 1 | ||||
Profound | 1 | ||||
Not recorded | 1 | ||||
Speech and language impairment | 6 (30) | 7 (37) | 0.73 | (0.19 to 2.79) | 0.651 |
Moderate | 4 | 5 | |||
Severe | 0 | 2 | |||
Profound | 2 | 0 | |||
Vision impairment | 1 (5) | 4 (21) | 0.20 | (0.02 to 1.96) | 0.166 |
Moderate | 0 | 2 | |||
Severe | 1 | 1 | |||
Not recorded | 0 | 1 | |||
Somatic impairments | |||||
Respiratory | 2 (10)†† | 1 (5)†† | 2.00 | (0.16 to 24.34) | 0.585 |
Gastrointestinal | 1 (5)‡‡ | 1 (5)†† | 0.95 | (0.06 to 16.31) | 0.970 |
Renal | 0 | 0 | |||
Hospital admission | |||||
After discharge from Neonatal care | 10 (50) | 10 (53) | 0.97 | (0.26 to 3.70) | 0.968 |
Dopamine (n=20)* | Placebo (n=20)* | ||||
Growth§§ | Mean (SD) | Mean (SD) | Δ | (95% CI)† | P value† |
Height (cm) | 83.9 (4.1) | 86.9 (3.6) | −3.1 | (−5.4 to −0.7) | 0.010 |
Weight (kg) | 10.6 (1.5) | 11.8 (1.6) | −1.2 | (−2.2 to −0.3) | 0.009 |
Head circumference (cm)¶¶ | 46.6 (1.9) | 47.7 (2.4) | −1.1 | (−2.4 to 0.2) | 0.097 |
*Unless otherwise stated.
†Difference in means (95% CI) and p value from linear random effects model with centre as a random effect.
‡n=19 in the dopamine group and n=18 in the placebo group.
§n=17 in the dopamine group and n=18 in the placebo group.
¶OR (95% CI) and p value from logistic random effects model with centre as a random effect. Outcome is impairment versus no impairment (reference).
**n=19 in the dopamine group.
††Moderate impairment.
‡‡Severe impairment.
§§Includes one infant with no primary or secondary outcomes available.
¶¶n=19 in the dopamine group.
CP, cerebral palsy.