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Table 2 Outcome of conservative PDA management in cohort studies compared to the Vermont Oxford Network database 2009 (Horbar et al. (2012))

From: Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)

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)††
  1. Data presented as number n and/or (%), median [interquartile range] or mean ± SD
  2. Percentage may differ due to missing values or lack of assessment
  3. §Supplemental oxygen need at a postmenstrual age of 36 weeks, Bell stage ≥2,  ≥ grade 3, * no or aberrant definition in article, †† morbidity among survivors (n = 38,017)
  4. CTG conservative treatment group, ETG early treatment group, STG symptomatic treatment group, VON Vermont Oxford Network; Rx pharmacotherapy, NEC Necrotizing enterocolitis, IVH Intraventricular haemorrhage, BPD Bronchopulmonary dysplasia, NA not available