Table 4.
p Value for intervention | ||||||||
Outcome | Infant age (months) | n | Control | FAB | Sleep | Combination | ∆ Four groups | ∆ Two groups* |
Infant sleep problem score†‡§ | ||||||||
Mother-rated | 4 | 718 | 2.0 (1.9) | 2.3 (1.9) | 2.2 (1.9) | 2.0 (2.0) | ||
6 | 701 | 2.2 (2.0) | 2.6 (1.9) | 2.4 (2.0) | 2.3 (1.9) | 0.176 | 0.961 | |
Partner-rated | 4 | 469 | 1.9 (1.8) | 2.3 (1.8) | 2.3 (1.8) | 2.2 (1.8) | ||
6 | 428 | 2.3 (1.8) | 2.5 (1.9) | 2.4 (1.8) | 2.3 (1.7) | 0.117 | 0.410 | |
Infant unsettled, n (%) | 4 | 711 | 11 (5.7) | 16 (9.0) | 11 (6.4) | 11 (6.5) | ||
6 | 700 | 15 (8.0) | 15 (8.3) | 11 (6.6) | 7 (4.2) | 0.557 | 0.375 | |
Sleep latency ≥30 min, n (%) | 4 | 715 | 10 (5.2%) | 10 (5.6%) | 16 (9.3%) | 14 (8.2%) | ||
6 | 701 | 18 (9.6%) | 15 (8.3%) | 22 (13.2%) | 5 (3.0%) | 0.038 | 0.160 | |
Recognise tired signs score¶ | 4 | 717 | 6.1 (0.9) | 6.0 (0.9) | 6.1 (0.9) | 6.1 (0.9) | ||
6 | 700 | 6.2 (0.8) | 6.1 (0.8) | 6.1 (0.9) | 6.3 (0.8) | 0.166 | 0.805 | |
Infant put to bed awake score¶ | 4 | 717 | 5.1 (1.8) | 5.1 (1.8) | 5.4 (1.7) | 5.4 (1.8) | ||
6 | 700 | 5.5 (1.8) | 5.2 (1.8) | 5.5 (1.8) | 5.6 (1.6) | 0.129 | 0.052 | |
No parental contact score¶ | 4 | 717 | 5.0 (1.8) | 5.0 (1.7) | 5.3 (1.9) | 5.0 (2.0) | ||
6 | 700 | 5.3 (1.8) | 5.1 (1.9) | 5.3 (1.9) | 5.1 (2.0) | 0.444 | 0.389 | |
Bedsharing, n (%) | 4 | 720 | 11 (5.6%) | 12 (6.6%) | 12 (7.0%) | 17 (9.9%) | ||
6 | 685 | 11 (6.0%) | 12 (6.9%) | 7 (4.1%) | 13 (8.2%) | – | – | |
Smoking allowed at home, n (%) | 4 | 717 | 4 (2.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | ||
6 | 687 | 1 (0.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | – | – | |
Smoking allowed in car when children present, n (%) | 4 | 702 | 2 (1.1%) | 3 (1.7%) | 2 (1.2%) | 0 (0.0%) | ||
6 | 686 | 1 (0.6%) | 1 (0.6%) | 3 (1.8%) | 3 (1.8%) | – | – | |
Sleeping on back, n (%) | 4 | 718 | 176 (90.3%) | 164 (91.1%) | 152 (88.9%) | 150 (87.2%) | 0.631 | 0.254 |
Sheepskin use, n (%) | 4 | 720 | 27 (13.9%) | 17 (9.4%) | 26 (15.1%) | 27 (15.7%) | 0.374 | 0.240 |
Data presented as mean (SD) unless stated otherwise.
*‘Sleep’ (control and FAB combined) versus ‘No Sleep’ (sleep and combination combined).
†Secondary outcome to the main RCT.30 All others variables are additional outcomes.
‡From a possible score of 1 (no problem) to 8 (large problem), thus higher score is better.
§Mean is geometric mean.
¶From a possible score of 1 (never) to 7 (always), thus higher score is better.
–, Model not investigated due to small number of events not allowing estimating intervention effects with stratification variables included.
FAB, food, activity and breastfeeding intervention; RCT, randomised controlled trial.