Summary of findings 1. Early systemic postnatal corticosteroids compared with placebo or no treatment for preventing bronchopulmonary dysplasia in preterm infants.
| Early systemic postnatal corticosteroids (dexamethasone and hydrocortisone) compared with placebo or no treatment for preventing bronchopulmonary dysplasia in preterm infants | ||||||
| Patient or population: preventing bronchopulmonary dysplasia in preterm infants Setting: multiple neonatal intensive care units, most from high‐income countries Intervention: early systemic postnatal corticosteroids Comparison: placebo or no treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo or no treatment | Risk with early systemic postnatal corticosteroids | |||||
| Mortality at latest reported age |
Study population (studies treating with dexamethasone or hydrocortisone) | RR 0.95 (0.85 to 1.06) | 4373 (31 RCTs) | ⊕⊕⊕⊕ HIGH | critical P = 0.05 for subgroup differences |
|
| 232 per 1000 | 221 per 1000 (197 to 246) | |||||
| Study population (subgroup of studies treating with dexamethasone) | RR 1.02 (0.90 to 1.16) | 2940 (20 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 236 per 1000 | 241 per 1000 (212 to 274) |
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| Study population (subgroup of studies treating with hydrocortisone) | RR 0.80 (0.65 to 0.99) | 1433 (11 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 225 per 1000 | 180 per 1000 (146 to 222) | |||||
| BPD (36 weeks' PMA) |
Study population (studies treating with dexamethasone or hydrocortisone) | RR 0.80 (0.73 to 0.88) | 4167 (26 RCTs) | ⊕⊕⊕⊝ MODERATEa | important P = 0.01 for subgroup differences |
|
| 308 per 1000 | 247 per 1000 (225 to 271) | |||||
| Study population (subgroup of studies treating with dexamethasone) | RR 0.72 (0.63 to 0.82) | 2791 (17 RCTs) | ⊕⊕⊕⊕ HIGH | important | ||
| 269 per 1000 | 194 per 1000 (170 to 221) | |||||
| Study population (subgroup of studies treating with hydrocortisone) | RR 0.92 (0.81 to 1.06) | 1376 (9 RCTs) | ⊕⊕⊕⊕ HIGH | important | ||
| 385 per 1000 | 354 per 1000 (312 to 408) | |||||
| Mortality or BPD at 36 weeks' PMA |
Study population (studies treating with dexamethasone or hydrocortisone) | RR 0.89 (0.84 to 0.94) | 4167 (26 RCTs) | ⊕⊕⊕⊕ HIGH | critical | |
| 515 per 1000 | 458 per 1000 (432 to 484) | |||||
| Study population (subgroup of studies treating with dexamethasone) | RR 0.88 (0.81 to 0.95 | 2791 (17 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 487 per 1000 | 429 per 1000 (395 to 463) | |||||
| Study population (subgroup of studies treating with hydrocortisone) | RR 0.90 (0.82 to 0.99 | 1376 (9 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 569 per 1000 | 512 per 1000 (467 to 563) | |||||
| Gastrointestinal perforation during primary hospitalisation |
Study population (studies treating with dexamethasone or hydrocortisone) | RR 1.84 (1.36 to 2.49) | 3040 (16 RCTs) | ⊕⊕⊕⊕ HIGH | important | |
| 39 per 1000 | 71 per 1000 (53 to 96) | |||||
| Study population (subgroup of studies treating with dexamethasone) | RR 1.73 (1.20 to 2.51 | 1936 (9 RCTs) | ⊕⊕⊕⊕ HIGH | important | ||
| 41 per 1000 | 71 per 1000 (50 to 104) | |||||
| Study population (subgroup of infants treated with hydrocortisone | RR 2.05 (1.21 to 3.47 | 1104 (7 RCTs) | ⊕⊕⊕⊕ HIGH | important | ||
| 34 per 1000 | 70 per 1000 (41 to 118) | |||||
| Cerebral palsy at latest reported age |
Study population (studies treating with dexamethasone or hydrocortisone) | RR 1.42 (1.06 to 1.91) | 1973 (13 RCTs) | ⊕⊕⊕⊕ HIGH | critical P = 0.09 for subgroup differences |
|
| 74 per 1000 | 106 per 1000 (79 to 142) | |||||
| Study population (subgroup of studies treating with dexamethasone) | RR 1.77 (1.21 to 2.58) | 921 (7 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 89 per 1000 | 158 per 1000 (108 to 230) | |||||
| Study population (subgroup of studies treating with hydrocortisone) | RR 1.05 (0.66 to 1.66) | 1052 (6 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 62 per 1000 | 65 per 1000 (41 to 103) | |||||
| Mortality or cerebral palsy at latest reported age |
Study population (studies treating with dexamethasone or hydrocortisone) | RR 1.03 (0.91 to 1.16) | 1973 (13 RCTs) | ⊕⊕⊕⊕ HIGH | critical P = 0.02 for subgroup differences |
|
| 335 per 1000 | 345 per 1000 (305 to 389) | |||||
| Study population (subgroup of studies treating with dexamethasone) | RR 1.18 (1.01 to 1.37) | 921 (7 RCTs) | ⊕⊕⊕⊕ HIGH | critical |
||
| 383 per 1000 | 452 per 1000 (387 to 525) | |||||
| Study population (subgroup of studies treating with hydrocortisone) | RR 0.86 (0.71 to 1.05) | 1052 (6 RCTs) | ⊕⊕⊕⊕ HIGH | critical | ||
| 295 per 1000 | 254 per 1000 (210 to 310) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BPD: bronchopulmonary dysplasia; CI: confidence interval; PMA: postmenstrual age; RCT: randomised controlled trial; RR: risk ratio. | ||||||
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GRADE Working Group grades of evidence. High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate. | ||||||
aDowngraded one level for serious study limitations owing to evidence of publication bias for studies overall, but not within subgroups.