Table 1.
Demographic, nutrient intake, and POM (primary outcome measure) data comparing original study population with follow-up population. Data are expressed as means (standard deviation). PN: parenteral nutrition; OFC: Occipitofrontal head circumference; SDS: standard deviation score.
| Original RCT | Neurodevelopmental FU (Follow up) | |||||
|---|---|---|---|---|---|---|
| Demographics | SCAMP (n = 74) |
Control (n = 76) |
p | SCAMP (n = 38) |
Control (n = 41) |
|
| Birthweight (g) | 900 (158) | 884 (183) | 925 (152) | 900 (185) | ||
| Birthweight (SDS) | −0.47 (0.79) | −0.47 (0.73) | −0.41 (0.83) | −0.53 (0.81) | ||
| Gestation (weeks) | 26.8 (1.3) | 26.6 (1.4) | 27.0 (1.2) | 26.8 (1.3) | ||
| Sex (male) | 44 (59.5%) | 39 (51.3%) | 22 (58%) | 24 (59%) | ||
| Nutrient intake | SCAMP (n = 66) |
Control (n = 69) |
SCAMP (n = 38) |
Control (n = 41) |
||
| Total protein d1–14 (g/kg/d) | 3.20 (0.28) | 2.68 (0.24) | <0.001 | 3.21 (0.32) | 2.68 (0.18) | <0.001 |
| PN protein d1–14 (g/kg/d) | 2.82 (0.51) | 2.26 (0.42) | <0.001 | 2.81 (0.55) | 2.24 (0.40) | <0.001 |
| Total energy d1–14 (kcal/kg/d) | 91 (7) | 81 (8) | <0.001 | 91 (7) | 82 (9) | <0.001 |
| PN energy d1–14 (kcal/kg/d) | 76 (14) | 64 (8) | <0.001 | 76 (14) | 64 (12) | <0.001 |
| Total protein d15–28 (g/kg/d) | 3.18 (0.49) | 3.08 (0.56) | 0.24 | 3.19 (0.44) | 3.20 (0.42) | |
| PN protein d15–28 (g/kg/d) | 1.09 (1.20) | 0.85 (1.03) | 0.20 | 1.20 (1.17) | 0.75 (0.85) | |
| Total energy d15–28 (kcal/kg/d) | 112 (15) | 109 (19) | 0.24 | 111 (15) | 113 (14) | |
| PN energy d15–28 (kcal/kg/d) | 31 (33) | 24 (29) | 0.16 | 35 (33) | 21 (24) | |
| Primary outcome measure | SCAMP (n = 66) |
Control (n = 69) |
SCAMP (n = 38) |
Control (n = 41) |
||
| OFC SDS (randomisation) | See reference [19] | −1.57 (0.82) | −1.50 (0.68) | |||
| ΔOFC 28 days (POM) | See reference [19] | 31 (9) | 26 (8) | |||
| ΔOFC SDS 28 days (POM) | See reference [19] | 0.04 (0.61) | −0.27 (0.63) | |||
| OFC SDS 36 weeks CGA | See reference [19] | −0.91 (1.12) | −1.31 (1.25) | |||