Table 3.
Complete‐case and multiple‐imputation analyses for composite outcome of mortality and abnormal development in 80 infants included in Triple P trial, from time of randomization until 2 years of corrected age
| Outcome | Progesterone | Placebo | Odds ratio (95% CI) | P |
|---|---|---|---|---|
| Complete‐case analysis | ||||
| n | 41 | 39 | ||
| Neonatal death | 1/41 (2) | 2/39 (5) | 0.46 (0.04–5.32) | 0.53 |
| Death up to 2 years of age | 1/41 (2) | 2/39 (5) | 0.46 (0.04–5.32) | 0.53 |
| No follow‐up | 11/40 (28) | 7/37 (19) | 0.62 (0.21–1.80) | 0.37 |
| Assessment at 2 years of age | ||||
| n | 29 | 30 | ||
| BSID‐III (cognitive or motor) | ||||
| ≤–1 SD* | 1/28 (4) | 1/29(3) | 1.04 (0.06–17.43) | 1.00 |
| ≤–2 SD | 0/28 (0) | 0/29 (0) | — | — |
| Abnormal CBCL† | 1/27 (4) | 4/27 (15) | 0.22 (0.02–2.12) | 0.35 |
| Physical problem‡ | 3/29 (10) | 2/27 (7) | 1.44 (0.22–9.37) | 1.00 |
| Abnormal developmental outcome§ | 5/29 (17) | 5/30 (17) | 0.97 (0.31–2.99) | 1.00 |
| Death or abnormal developmental outcome | 6/41 (15) | 7/39 (18) | 0.78 (0.24–2.58) | 0.69 |
| Multiple imputation¶ | ||||
| n | 41 | 39 | ||
| BSID‐III (cognitive or motor) ≤–1 SD* | 6.4/40 (16) | 4.7/37 (13) | 0.77 (0.17–3.60) | 0.74 |
| Abnormal CBCL† | 6.4/40 (16) | 7.7/37 (21) | 1.37 (0.41–4.55) | 0.61 |
| Physical problem‡ | 3.8/40 (10) | 4.3/37 (12) | 1.17 (0.24–5.70) | 0.85 |
| Abnormal developmental outcome§ | 13.4/40 (34) | 11.7/37 (32) | 0.94 (0.45–1.99) | 0.87 |
| Death or abnormal developmental outcome** | 14.4/41 (35) | 13.7/39 (35) | 1.00 (0.50–1.98) | 0.99 |
Data are given as n/N (%) unless otherwise indicated.
Normal or abnormal scores were based on mean score (100) and SD of predefined reference group.
Abnormal BSID‐III is defined as score ≤ –1 SD below normative mean (100).
Defined as score in clinical range (> 97th percentile).
Defined as at least two hospital admissions and/or at least two operations in 2 years after birth.
Composite of BSID‐III score ≤–1 SD or CBCL score in clinical range or physical problem (at least two hospital admissions and/or at least two operations in 2 years after birth).
Pooled outcomes of 10 imputed datasets.
Composite score of neonatal death (no imputed data) and abnormal developmental outcome (with imputed data). BSID‐III, Bayley Scales of Infant and Toddler Development, third edition; CBCL, Child Behavior Checklist.