Table 1.
Characteristics of the included studies
| Dash 2015 | El Mashad 2017 | Meena 2020 | Davidson 2021 | |
|---|---|---|---|---|
| Country | India | Egypt | India | USA |
| Funding source | None | None | None | None |
| Inclusion criteria | BW ≤ 1500 g and Echo in ≤ 48 hrs of birth showing HsPDA | GA< 28 wks or BW< 1500 g and HsPDA diagnosed on basis of Echo and Clinical exam within < 2 wks of birth | GA < 37 wks and HsPDA diagnosed clinically and confirmed by Echo in first 28 postnatal days of life | GA between 22–32 wks and BW < 1500 g at ≤ 21 days of age with HsPDA diagnosed clinically and confirmed by Echo |
| HsPDA Echo criteria | PDA ≥ 1.5 mm with Left-to-right shunt, and LA:AO ratio > 1.5:1 | LA dilatation (LA:AO > 1.6), diastolic turbulence (backflow) on Doppler in the pulmonary artery, internal diameter of duct > 1.5 mm, and reverse end-diastolic flow in the descending aorta/mesenteric artery | Internal diameter of the duct > 1.5 mm, left atrial dilatation (LA/Ao > 1.4), diastolic turbulence (backflow) on Doppler in the pulmonary artery, and reversed end-diastolic flow in the descending aorta/mesenteric artery | Left-to-right ductal flow and 2 of the 3 following: ductal size ≥ 1.5 mm at smallest diameter, reversal of flow in descending aorta or LA:AO ratio ≥ 1.5 |
| INTERVENTION 1 | PO acetaminophen at 15 mg/kg/dose four times daily for 7 days | IV acetaminophen at 15 mg/kg/dose four times daily for 3 days | IV acetaminophen at 15 mg/kg/dose four times daily for 3 days | IV acetaminophen at 15 mg/kg/dose four times daily for 3 days |
| INTERVENTION 2 | IV indomethacin at 0.2 mg/kg/dose once daily for 3 days | IV indomethacin at 0.2 mg/kg/dose twice daily for 3 doses | PO indomethacin twice daily for 3 doses at: Starting dose: 0.2 mg/kg following doses: * Infants < 2 days: 0.1 mg/kg * Infants 2–7 days: 0.2 mg/kg * infants > 7 days: 0.25 mg/kg |
IV indomethacin twice daily for 3 doses at: * Infants 2–7 days: 0.2 mg/kg for all doses * Infants > 7 days: 0.2 mg/kg for 1st dose and 0.25 mg/kg for subsequent doses |
| Sample size PCM vs. Indo |
38 vs. 39 | 100 vs. 100 | 35 vs. 35 | 17 vs. 21 |
| Loss to follow-up for primary outcome | 4/77 (5.2%) | None | None | 1/38 (2.6%) |
| GA mean (SD) PCM vs. Indo |
28.5 (2.7) vs. 28.9 (2.6) | 26 (1.9) vs. 26 (2.1) | 32.14 (2.01) vs. 31.77(2.26) | 25.7 (1.4) vs. 25.3 (1.8) |
| BW mean (SD) PCM vs. Indo |
989 (299) vs. 1027 (262) | 1100 (130) vs. 1100 (140) | 1440 (340) vs. 1410 (320) | 785 (203) vs. 756 (241) |
| Male PCM vs. Indo |
36.9% vs. 33.3% | 60% vs. 60% | 51.4% vs. 42.9 | 53% vs. 40% |
| PDA size (mm) mean (SD) PCM vs. Indo |
2.02 (0.42) vs. 2.11 (0.53) | 2.7 (0.6) vs. 2.7 (0.7) | 1.85 (0.43) vs. 1.82 (0.28) | 2.7 (0.7) vs. 2.9 (0.7) |
| Postnatal age for diagnosis or Rx PCM vs. Indo |
Mean (SD) (hours) 14.7 (8.4) vs. 15.9 (11.8) |
Mean (SD) (days) 2.7 (4.4) vs. 3.1 (5.1) |
Mean (SD) (days) 9.02 (3.43) vs. 10.85 (4.25) |
Median (IQR) (days) 8 (7,11) vs. 6.5 (4,9.3) |
| Primary outcome | PDA closure | PDA closure | PDA closure | Successful PDA treatment (No longer HsPDA) |
AO, aortic root; BW, birth weight; g, gram; GA, gestational age; hr, hour; HsPDA, hemodynamically significant patent ductus arteriosus; Indo, indomethacin; IV, intravenous; LA, left atrial; PCM, paracetamol (acetaminophen); PDA, patent ductus arteriosus; PO, per oral; Rx, treatment.