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

Hundscheid, Tim; Onland, Wes; van Overmeire, Bart; Dijk, Peter; van Kaam, Anton H. L. C.; Dijkman, Koen P.; Kooi, Elisabeth M. W.; Villamor, Eduardo; Kroon, André A.; Visser, Remco; Vijlbrief, Daniel C.; de Tollenaer, Susanne M.; Cools, Filip; van Laere, David; Johansson, Anne-Britt; Hocq, Catheline; Zecic, Alexandra; Adang, Eddy; Donders, Rogier; de Vries, Willem; van Heijst, Arno F. J.; de Boode, Willem P.

doi:10.1186/s12887-018-1215-7

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 R_x and/or ligation	CTG vs R_x and/or ligation	CTG description	CTG vs R_x and/or ligation	CTG vs R_x and/or ligation	CTG vs STG vs ETG	CTG vs R_x	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)^††

Data presented as number n and/or (%), median [interquartile range] or mean ± SD
Percentage may differ due to missing values or lack of assessment
^§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)
CTG conservative treatment group, ETG early treatment group, STG symptomatic treatment group, VON Vermont Oxford Network; R_x pharmacotherapy, NEC Necrotizing enterocolitis, IVH Intraventricular haemorrhage, BPD Bronchopulmonary dysplasia, NA not available

Back to article page

ISSN: 1471-2431

Contact us

Submission enquiries: bmcpediatrics@biomedcentral.com
General enquiries: ORSupport@springernature.com

BMC Pediatrics

Contact us