How does early (within 7 days) treatment compare with expectant management of hemodynamically significant patent ductus arteriosus (PDA) in preterm infants?

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.

Download Full-text

Predictive value of serum NT-proBNP concentrations for assessment hemodynamically significant patent ductus arteriosus in very preterm infants

Modern pediatrics. Ukraine ◽

10.15574/sp.2021.113.28 ◽

2021 ◽

pp. 28-36

Author(s):

S.O. Potsiurko ◽

◽

D.O. Dobryanskyy ◽

L.B. Sekretar ◽

◽

...

Keyword(s):

Patent Ductus Arteriosus ◽

Preterm Infants ◽

Predictive Value ◽

Ductus Arteriosus ◽

Randomized Study ◽

Expectant Management ◽

Very Preterm Infants ◽

Very Preterm ◽

Management Approaches ◽

Patent Ductus

Hemodynamically significant patent ductus arteriosus (PDA) is a common complication in very preterm infants born at less than 32 weeks of gestation. At the same time, currently, there are no uniform criteria to identify the actual hemodynamic significance of PDA and generally accepted management approaches to such infants. Purpose — to assess the predictive value of serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels for hemodynamically significant PDA in very preterm infants. Materials and methods. Fifty-two preterm infants with gestational age <32 weeks, chronological age <72 h, and PDA diameter >1.5 mm were involved in a randomized study. Twenty-seven (52%) of them were treated with ibuprofen or paracetamol starting within the first 3 days of life. Expectant management was applied to 25 (48%) infants. All patients underwent daily echocardiographic and two serum NT-proBNP measurements within the first 10 days after birth. According to the results of echocardiographic and clinical monitoring, 2 groups of patients were formed retrospectively. In 22 (42%) of them hemodynamically significant PDA (hsPDA) was diagnosed, and 30 (58%) had hemodynamically insignificant ductus arteriosus. Results. The percentage of infants who received pharmacological PDA treatment was not significantly different between the groups (p>0.05). Serum NT-proBNP concentrations at the median age of 2 and 8 days were significantly higher in infants with hsPDA (p<0.01). By the eighth day of life, the NT-proBNP level in both groups significantly decreased but remained considerably higher in newborns with hsPDA. Serum NT-proBNP concentrations on the second-third day of life could reliably predict hsPDA (AUC=0.93; 95% confidence interval: 0.86–1.0; p<0.05). Conclusions. Serum NT-proBNP concentrations on the second day of life >12000 pg/ml could reliably predict hsPDA. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of these Institutes. The informed consent of the patient was obtained for conducting the studies. No conflict of interest was declared by the authors. Key words: hemodynamically significant patent ductus arteriosus, PDA, NT-proBNP, prognostic value, very preterm infants.

Download Full-text