Background
Meta-analysis of randomised controlled trials evaluating PDA treatment
Outcome | Studies | Participants | Risk Ratio | 95%-CI |
---|---|---|---|---|
Mortality | 31 | 3534 | 0.98 | 0.84–1.13 |
BPD (total) | 23 | 3531 | 1.07 | 0.98–1.16 |
BPD (oxygen need at PNA 28 days) | 16 | 1395 | 1.07 | 0.94–1.22 |
BPD (oxygen need at PMA 36 weeks) | 8 | 2136 | 1.06 | 0.95–1.20 |
NEC | 23 | 3285 | 1.05 | 0.83–1.32 |
Death or BPD at PMA 36 weeks | 7 | 2096 | 1.05 | 0.97–1.14 |
IVH | 20 | 3150 | 0.98 | 0.88–1.10 |
Failure of ductal closure | 23 | 1619 | 0.44 | 0.38–0.50 |
Randomised controlled trials evaluating expectative management
Studies | Vanhaesebrouck et al. (2007) | Mirea et al. (2012) | Sadeck et al. (2014) | Rolland et al. (2015) | Sung et al. (2016) | Lokku et al. (2017) | Letshwiti et al. (2017) | Slaughter et al. (2017) | Mohamed et al. (2017) | Horbar et al. (2012) |
---|---|---|---|---|---|---|---|---|---|---|
Study design | ||||||||||
Study period | 1 Jan 2005–31 Dec 2005 | 2004–2008 | 1 Jan 2010–31 Dec 2011 | 1 Jun 2008–31 Jul 2010 | 1 Jul 2009–30 Jun 2014 | 2006–2012 | Jan 2004–Feb 2011 | 1 Jan 2006–31 Dec 2013 | 1 Jan 2001–31 Dec 2014 | 2000–2009 |
Study design | Prospective Monocentre | Retrospective Multicentre | Retrospective Multicentre | Retrospective Monocentre | Retrospective Monocentre | Retrospective Multicentre | Retrospective Monocentre | Retrospective Multicentre | Retrospective Monocentre | Retrospective Multicentre |
Compared cohort(s) | CTG vs VON database 2004 | CTG vs Rx and/or ligation | CTG vs Rx and/or ligation | CTG description | CTG vs Rx and/or ligation | CTG vs Rx and/or ligation | CTG vs STG vs ETG | CTG vs Rx | CTG vs STG | 2009 vs 2000–2008 |
Total patients | 30 | 3556 | 494 | 103 | 178 | 5824 | 371 | 12,018 | 643 | 305,770 |
Demographics in CTG patients | ||||||||||
Patients | 30 | 577 | 187 | 91 | 97 | 1486 | 72 | 8130 | 228 | 43,566 in 2009 |
Patients with PDA | 10 | 577 | 187 | 70 | 97 | 1486 | 34 | 8130 | NA | NA |
PDA treatment | 0 (0) | 0 (0) | 0 (0) | 1 (1.4) | 2 (2.1) | 0 (0) | 5 (14.7) | 0 (0) | NA | NA |
Male sex | 14 (46.7) | 321 (55.6) | 91 (48.7) | 54 (59.3) | 54 (55.7) | 811 (54.6) | 16 (47.1) | 4302 (52.9) | 122 (53.5) | 51.1% in 2000–2009 |
Gestational age, in weeks | 26.6 [25–30] | 28.3 ± 2.3 | 27.6 ± 2.2 | 26.3 ± 1.0 | 24.5 ± 1.0 | 28.2 ± 2.4 | 27.4 ± 2.7 | ≤ 28 | 28.0 ± 3.4 | 28.1 in 2009 |
Birthweight, in grams | 994 [600–1484] | NA | 772.0 ± 142.3 | 823 ± 164 | 718 ± 137 | NA | 1010 ± 250 | NA | 1016 ± 340 | 1055 in 2009 |
Outcome in CTG patients | ||||||||||
Mortality | (12) | 72 (12.5) | 96 (51.3) | (17) | 9 (9.3) | 160 (10.8) | (3) | 1067 (13.1) | 24 (12.1) | (12.7) |
BPD§ | (7) | 138 (27.1) | 48 (25.7) | (35) | 35 (38) | 307 (23.1) | (18) | 2509 (30.9) | 9 (5.0) | (26.3)†† |
NEC† | (0) | 34 (6.0) | 14 (7.5)* | (3)* | 12 (12.4) | 102 (6.9) | (6)* | NA | 20 (8.8)* | (5.3)†† |
IVH‡ | (2) | 105 (21.6) | 37 (19.8) | (21) | 12 (12.4) | 251 (16.9) | (9) | NA | 14 (6.6) | (6.1)†† |
Research gap
Methods/design
Study aims
Study design and settings
Ethical consideration
Definitions
Primary outcome definition
Secondary outcome definition
Economic evaluation
Cost-effectiveness analysis
Budget impact analysis
Randomisation process
Withdrawal and replacement of individual subjects
I. Exclusion of other causes of cardiovascular failure (e.g. sepsis or congenital heart defect) | |
AND | |
II. Clinical findings of cardiovascular failure secondary to significant ductal left-to-right shunting: a. Signs of systemic hypoperfusion (refractory systemic hypotension and/or elevated serum lactate concentration (> 2.5 mmol/L)) and; b. Signs of pulmonary hyperperfusion (prolonged ventilator dependency). | |
AND | |
III. Echocardiographic findings of significant ductal left-to-right shunting a. Diameter of PDA > 1.5 mm, and; b. Unrestricted ductal left-to-right shunting (‘pulsatile pattern’): end-diastolic flow velocity < 50% of peak flow velocity, and; c. End-diastolic flow velocity left pulmonary artery > 0.3 m/s, and; d. Left atrial to aortic ratio > 1.5. AND a. Severe left ventricular failure (mitral regurgitation), and; b. Disturbed end-organ perfusion (retrograde diastolic blood flow in descending aorta). |
I. Exclusion of other causes of cardiovascular failure (e.g. sepsis or congenital heart defect) | |
AND | |
II. Clinical findings of cardiovascular failure secondary to significant ductal left-to-right shunting: a. Signs of systemic hypoperfusion (refractory systemic hypotension and/or elevated serum lactate concentration (> 2.5 mmol/L)) and/or; b. Signs of pulmonary hyperperfusion (prolonged ventilator dependency). | |
AND | |
III. Echocardiographic findings of significant ductal left-to-right shunting a. Diameter of PDA > 1.5 mm, and; b. Unrestricted ductal left-to-right shunting (‘pulsatile pattern’): end-diastolic flow velocity < 50% of peak flow velocity, and/or; c. End-diastolic flow velocity left pulmonary artery > 0.3 m/s, and/or; d. Left atrial to aortic ratio > 1.5. AND/OR a. Severe left ventricular failure (mitral regurgitation), and/or; b. Disturbed end-organ perfusion (retrograde diastolic blood flow in descending aorta). |