6. Interventions (pharmacological or surgical) for prevention of PDA and related complications in preterm infants.
|
Interventions |
Prophylactic indomethacin | Prophylactic ibuprofen | Prophylactic acetaminophen | Prophylactic surgical ligation | Chest shielding during phototherapy | Restriction of fluid intake | ||
| Outcomes | ||||||||
| Severe intraventricular haemorrhage | 0.66, 95% CI 0.53 to 0.82; 14 RCTs, N = 2588 | 0.67, 95% CI 0.45 to 1.00; 7 RCTs, N = 925; moderate‐certainty evidence | 1.0, 95% CI 9 0.07 to 16.39; 1 RCT, N = 48 | 0.81, 95% CI 0.52, to 1.28; 1 RCT, N = 76 | 0.64, 95% CI 0.22 to 1.85; 2 RCTs, N = 128 | ‐ | ||
| Death or moderate/severe neurodevelopmental disability | 1.02, 95% CI 0.90 to 1.15; 3 RCTs, N = 1491 | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| PDA confirmed on echocardiogram | 0.29, 95% CI 0.22 to 0.38; 7 RCTs, N = 965 | 0.39, 95% CI 0.31 to 0.48; 9 RCTs, N = 1029 | 0.27, 95% CI 0.18 to 0.42; 3 RCTs, N = 240 | ‐ | 0.92, 95% CI 0.52 to 1.64; 1 RCT, N = 54 | 0.52, 95% CI 0.37 to 0.73; 4 RCTs, N = 526 | ||
| Haemodynamically significant PDA | ‐ | ‐ | ‐ | ‐ | 0.23, 95% CI 0.05 to 1.01; 1 RCT, N = 74 | ‐ | ||
| Need for open‐label medical treatment | ‐ | 0.17, 95% CI 0.11 to 0.26; 6 RCTs, N = 776 | ‐ | ‐ | 0.12, 95% CI 0.02 to 0.88; 1 RCT, N = 74 | ‐ | ||
| Need for surgical ligation or transcatheter occlusion | 0.51, 95% CI 0.37 to 0.71; 8 RCTs, N = 1791 | 0.46, 95% CI 0.22 to 0.96; 7 RCTs, N = 925 | ‐ | ‐ | 0.35, 95% CI 0.01 to 8.36; 1 RCT, N = 74 | ‐ | ||
| Chronic lung disease | Oxygen at 28 postnatal days | 1.08, 95% CI 0.92 to 1.26; 9 RCTs, N = 1022 | 0.88, 95% CI 0.32 to 2.42; 1 RCT, N = 41 | 0.69, 95% CI 0.32 to 1.48; 1 RCT, N = 48 | ‐ | ‐ | ‐ | |
| Oxygen at 36 weeks' PMA | 1.06, 95% CI 0.92 to 1.22; 1 RCT, N = 999 | 1.06, 95% CI 0.89 to 1.26; 5 RCTs, N = 817 | 0.36, 95% CI 0.02 to 8.45; 1 RCT, N = 48 | 1.07, 95% CI 0.68 to 1.69; 1 RCT, N = 48 | 0.85, 95% CI 0.63 to 1.14; 4 RCTs, N = 526 | |||
| Unspecified age at diagnosis | ‐ | 0.94, 95% CI 0.51 to 1.72; 2 RCTs, N = 99 | ‐ | ‐ | ‐ | |||
| Intraventricular haemorrhage (any degree) | 0.88, 95% CI 0.80 to 0.98; 14 RCTs, N = 2532 | 0.96, 95% CI 0.78 to 1.17); 6 RCTs, N = 901 | ‐ | ‐ | 0.53, 95% CI 0.10 to 2.71; 1 RCT, N = 74 | 0.74, 95% CI 0.48 to 1.14; 3 RCTs, N = 356 | ||
| Pulmonary haemorrhage | 0.84, 95% CI 0.66 to 1.07; 4 RCTs, N = 1591 | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| Retinopathy of prematurity | Any stage | 1.02, 95% CI 0.92 to 1.12; 5 RCTs, N = 1571 | 1.01, 95% CI 0.73 to 1.38; 5 RCTs, N = 369 | ‐ | 0.67, 95% CI 0.31 to 1.43; 1 RCT, N = 43 | 0.53, 95% CI 0.10 to 2.71; 1 RCT, N = 74 | ‐ | |
| Severe/requiring treatment | 1.75, 95% CI 0.92 to 3.34; 2 RCTs, N = 289 | ‐ | 3.25, 95% CI 0.14 to 76.01; 1 RCT, N = 48 | 0.32, 95% CI 0.04 to 2.82; 1 RCT, N = 43 | ‐ | ‐ | ||
| Duration of hospitalisation (days) | ‐ | MD 1.30 days, 95% CI ‐3.07 to 5.67; 6 RCTs, N = 447 | ‐ | ‐ | MD ‐8.05 days, 95% CI ‐18.04 to 1.94;2 RCTs, N = 128 | ‐ | ||
| Moderate/severe neurodevelopmental disability | 0.96, 95% CI 0.79 to 1.17; 3 RCTs, N = 1286 | ‐ | ‐ | ‐ | ‐ | ‐ | ||
| All‐cause mortality | Mortality during hospital stay | 0.82, 95% CI 0.65 to 1.03; 17 RCTs, N = 1567 | 0.90, 95% CI 0.62 to 1.30; 4 RCTs, N = 700 | 0.59, 95% CI 0.24 to 1.44; 3 RCTs, N = 240; low‐certainty evidence | ‐ | 1.68, 95% CI 0.75 to 3.78; 2 RCTs, N = 128 | 0.81, 95% CI 0.54 to 1.23; 5 RCTs, N = 582 | |
| Neonatal mortality (< 28 days) | ‐ | 0.93, 95% CI 0.50 to 1.74; 6 RCTs, N = 342 | ‐ | 0.88, 95% CI 0.53 to 1.45; 1 RCT, N = 84 | 1.06, 95% CI 0.16 to 7.10; 1 RCT, N = 74 | ‐ | ||
| Mortality at 1‐year, or at latest follow‐up | 0.96, 95% CI 0.81 to 1.12; 18 RCTs, N = 2769 | ‐ | ‐ | 1.06, 95% CI 0.75 to 1.49; 1 RCT, N = 84 | ‐ | ‐ | ||
| Mortality before 36 weeks' postmenstrual age | ‐ | 0.96, 95% CI 0.56 to 1.66; 1 RCT, N = 131 | ‐ | ‐ | ‐ | ‐ | ||
| Necrotising enterocolitis | 1.09, 95% CI 0.82 to 1.46; 12 RCTs, N = 2401 | 0.96, 95% CI 0.61 to 1.50; 9 RCTs, N = 1028 | 0.36, 95% CI 0.02 to 8.45; 1 RCT, N = 48 | 0.25, 95% CI 0.08 to 0.83; 1 RCT, N = 84 | ‐ | 0.43, 95% CI 0.21 to 0.87; 4 RCTs, N = 526 | ||
| Gastrointestinal perforation | 1.13, 95% CI 0.71 to 1.79; 1 RCT, N = 1202 | 4.88, 95% CI 0.87 to 27.36; 2 RCTs, N = 167 | ‐ | ‐ | ‐ | ‐ | ||
| Gastrointestinal bleeding | ‐ | 2.05, 95% CI 1.19 to 3.51; 5 RCTs, N = 282; low‐certainty evidence | ‐ | ‐ | ‐ | ‐ | ||
| Oliguria | 1.90, 95% CI 1.45 to 2.47; 8 RCTs, N = 2115 | 1.45, 95% CI 1.04 to 2.02; 4 RCTs, N = 747; high‐certainty evidence | 0.78, 95% CI 0.29 to 2.11; 1 RCT, N = 48 | ‐ | ‐ | ‐ | ||
| Serum/plasma levels of creatinine after treatment | ‐ | WMD* 0.09, 95% CI 0.05 to 0.13; 6 RCTs, N = 800 | ‐ | ‐ | ‐ | ‐ | ||
| Increase in serum/plasma creatinine after treatment | 1.09, 95% CI 0.47 to 1.79; 4 RCTs, N = 618 | 3.70, 95% CI 1.05 to 12.98; 2 RCTs, N = 285 | ‐ | ‐ | ‐ | ‐ | ||
| Serum/plasma bilirubin after treatment | ‐ | ‐ | MD 1 µmol/L, 95% CI ‐10.35 to 12.35; 1 RCT, N = 48 | ‐ | ‐ | ‐ | ||
CI: confidence interval; MD: mean difference; PDA: patent ductus arteriosus; PMA: post menstrual age; RCT: randomised controlled trials; WMD: weighted mean difference
Comparisons presented are intervention versus placebo.
Data presented as risk ratio (RR), unless otherwise specified; certainty of evidence added when available from review.
*WMD presented as reported in the respective review