scholarly journals Factors Associated With Benefit of Treatment of Patent Ductus Arteriosus in Preterm Infants: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 9 ◽  
Author(s):  
Esther J. S. Jansen ◽  
Tim Hundscheid ◽  
Wes Onland ◽  
Elisabeth M. W. Kooi ◽  
Peter Andriessen ◽  
...  
Keyword(s):  
Birth Weight ◽  
Patent Ductus Arteriosus ◽  
Preterm Infants ◽  
Outcome Measures ◽  
Pharmacological Treatment ◽  
Meta Analysis ◽  
Ductus Arteriosus ◽  
Extremely Low Birth Weight ◽  
Grade 3 ◽  
Patent Ductus

Context: There is an ongoing debate on the optimal management of patent ductus arteriosus (PDA) in preterm infants. Identifying subgroup of infants who would benefit from pharmacological treatment might help.Objective: To investigate the modulating effect of the differences in methodological quality, the rate of open-label treatment, and patient characteristics on relevant outcome measures in randomized controlled trials (RCTs).Data Sources: Electronic database search between 1950 and May 2020.Study Selection: RCTs that assessed pharmacological treatment compared to placebo/no treatment.Data Extraction: Data is extracted following the PRISMA guidelines. Outcome measures were failure to ductal closure, surgical ligation, incidence of necrotizing enterocolitis, bronchopulmonary dysplasia, sepsis, periventricular leukomalacia, intraventricular hemorrhage (IVH) grade ≥3, retinopathy of prematurity and mortality.Results: Forty-seven studies were eligible. The incidence of IVH grade ≥3 was lower in the treated infants compared to the placebo/no treatment (RR 0.77, 95% CI 0.64–0.94) and in the subgroups of infants with either a gestational age <28 weeks (RR 0.77, 95% CI 0.61–0.98), a birth weight <1,000 g (RR 0.77, 95% CI 0.61–0.97), or if untargeted treatment with indomethacin was started <24 h after birth (RR 0.70, 95% CI 0.54–0.90).Limitations: Statistical heterogeneity caused by missing data and variable definitions of outcome parameters.Conclusions: Although the quality of evidence is low, this meta-analysis suggests that pharmacological treatment of PDA reduces severe IVH in extremely preterm, extremely low birth weight infants or if treatment with indomethacin was started <24 h after birth. No other beneficial effects of pharmacological treatment were found.

scholarly journals Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tim Hundscheid ◽  
Rogier Donders ◽  
Wes Onland ◽  
Elisabeth M. W. Kooi ◽  
Daniel C. Vijlbrief ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Patent Ductus Arteriosus ◽  
Preterm Infants ◽  
Pharmacological Treatment ◽  
Ductus Arteriosus ◽  
Expectant Management ◽  
The United States ◽  
Statistical Analysis Plan ◽  
Short Term ◽  
Patent Ductus

Abstract Background Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. Methods/design The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24–72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. Trial registration ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.

Role of Transcatheter patent ductus arteriosus closure in extremely low birth weight infants

2018 ◽  
Vol 93 (1) ◽  
pp. 89-96 ◽  
Author(s):  
Shyam Sathanandam ◽  
Kaitlin Balduf ◽  
Sandeep Chilakala ◽  
Kristen Washington ◽  
Kimberly Allen ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Patent Ductus Arteriosus ◽  
Ductus Arteriosus ◽  
Extremely Low Birth Weight ◽  
Low Birth Weight Infants ◽  
Patent Ductus Arteriosus Closure ◽  
Patent Ductus

Efficiency and Safety of Patent Ductus Arteriosus Surgical Ligation in Extremely Low Birth Weight Infants Without Chest Tube Placement

2021 ◽  
Author(s):  
Georgios Kourelis ◽  
Meletios Kanakis ◽  
Constantinos Loukas ◽  
Felicia Kakava ◽  
Konstantinos Kyriakoulis ◽  
...  
Keyword(s):  
Birth Weight ◽  
Patent Ductus Arteriosus ◽  
Chest Tube ◽  
Ductus Arteriosus ◽  
Extremely Low Birth Weight ◽  
Tube Placement ◽  
Chest Tube Placement ◽  
Surgical Ligation ◽  
Patent Ductus

AbstractPatent ductus arteriosus (PDA) has been associated with increased morbidity and mortality in preterm infants. Surgical ligation (SL) is generally performed in symptomatic infants when medical management is contraindicated or has failed. We retrospectively reviewed our institution's experience in surgical management of PDA for extremely low birth weight (ELBW) infants without chest tube placement assessing its efficiency and safety. We evaluated 17 consecutive ELBW infants undergoing SL for symptomatic PDA (January 2012–January 2018) with subsequent follow-up for 6 months postdischarge. Patients consisted of 9 (53%) females and 8 (47%) males. Mean gestational age (GA) at birth was 27.9 ± 2.1 weeks. Median values for surgical age (SA) from birth to operation was 10 days (interquartile range [IQR]: 8–12); PDA diameter 3.4 mm (IQR: 3.2–3.5); surgical weight (SW) 750 g (IQR: 680–850); and days of mechanical ventilation (DMV) as estimated by Kaplan–Meier curve 22 days (95% confidence interval: 14.2–29.8). We observed a statistically significant negative association between DMV and GA at birth (rho = − 0.587, p = 0.017), SA (rho = − 0.629, p = 0.009) and SW (rho = − 0.737, p = 0.001). One patient experienced left laryngeal nerve palsy confirmed by laryngoscopy. Otherwise, there were no adverse events to include surgical-related mortality, recurrence of PDA, or need for chest tube placement during follow-up. SL of PDA in ELBW infants without chest tube placement is both efficient and safe. Universal consensus recommendations for the management of PDA in ELBW neonates are needed. Further study is required regarding the use of the less invasive option of percutaneous PDA closure in ELBW infants.

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