Effects of therapeutic approach on the neonatal evolution of very low birth weight infants with patent ductus arteriosus

Sadeck, Lílian S. R.; Leone, Cléa Rodrigues; Procianoy, Renato Soibelmann; Guinsburg, Ruth; Martinez, Francisco Eulógio; Elisabeth, M.; Fiori, Renato Machado; Ferrari, Lígia S L; Menezes, Jucille A.; Venzon, Paulyne Stadler; Luiz, José; Nunes, Marynea V.; Anchieta, Lêni Márcia

doi:10.1016/j.rchipe.2014.04.001

Cited by 4 publications

(6 citation statements)

References 17 publications

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“…The flow diagram of the search process is shown in Figure S1. Of 964 potentially relevant studies, 30 (including 12639 infants) were included (13, 16-20, 37-60). Their characteristics are summarized in Table S1.…”

Section: Resultsmentioning

confidence: 99%

Association between endotypes of prematurity and pharmacological closure of patent ductus arteriosus: A systematic review and meta-analysis

González-Luis

Borges-Lujan

Villamor

2022

Preprint

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Endotypes leading to very and extremely preterm birth are clustered into two groups: infection/inflammation and dysfunctional placentation. We conducted a systematic review of observational studies exploring the association between these two endotypes and the pharmacological closure of patent ductus arteriosus (PDA) induced by cyclooxygenase (COX) inhibitors. Chorioamnionitis represented the infectious-inflammatory endotype, while dysfunctional placentation proxies were hypertensive disorders of pregnancy (HDP) and small for gestational age (SGA) or intrauterine growth restriction. PubMed/Medline and Embase databases were searched. The random-effects odds ratio (OR) and 95% confidence interval (CI) were calculated for each association. We included 30 studies (12639 infants). Meta-analysis showed a significant association between exposure to HDP and increased rate of pharmacological closure of PDA (17 studies, OR 1.41, 95% CI 1.10-1.81, p=0.006). In contrast, neither chorioamnionitis (13 studies, OR 0.75, 95% CI 0.47-1.18, p=0.211) nor SGA (17 studies, OR 1.20, 95% CI 0.96-1.50, p=0.115) were significantly associated with the response to therapy. Subgroup analyses showed that the higher response to COX inhibitors in the HDP group was significant for indomethacin (OR 1.568, 95% CI 1.147-2.141, p=0.005) but not for ibuprofen (OR 1.107, 95% CI 0.248-4.392, p=0.894) or for the studies using both drugs (OR 1.280, 95% CI 0.935-1.751, p=0.124). However, meta-regression showed that this difference between the drugs was not statistically significant (p=404). In conclusion, our data suggest that the pathologic condition that triggers prematurity may alter the response to pharmacological treatment of PDA. The DA of infants exposed to HDP appears to be more responsive to COX inhibitors.

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Section: Resultsmentioning

confidence: 99%

Association between endotypes of prematurity and pharmacological closure of patent ductus arteriosus: A systematic review and meta-analysis

González-Luis

Borges-Lujan

Villamor

2022

Preprint

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“…In summary, a single dose of indomethacin at 12 h of age is associated with short-and long-term benefits in very premature infants. Given the recent trend away from prophylactic indomethacin use [54] and emerging reports of increased morbidity and mortality among infants who fail to spontaneously close the ductus arteriosus [55][56][57][58][59][60][61][62], neonatologists may consider using a single-dose prophylactic regimen to gain the benefits of ductus closure with limited drug exposure. Prospective studies are needed to determine the optimal timing and broad applicability of this approach, perhaps combined with early targeted cardiac ultrasound [11,63,64].…”

Section: Discussionmentioning

confidence: 99%

Outcomes in infants < 29 weeks of gestation following single-dose prophylactic indomethacin

et al. 2020

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Background Prophylactic indomethacin (3 doses) decreases patent ductus arteriosus (PDA) and intraventricular hemorrhage (IVH) in preterm infants. The study aim was to determine whether single-dose indomethacin (SD-INDO) decreases PDA, IVH, and improves motor function. Methods A retrospective cohort (2007-2014) compared infants born < 29 weeks who did (n = 299) or did not (n = 85) receive SD-INDO and estimated outcomes association with ordinal logistic regression, adjusting for multiple variables using propensity scores. Results Infants who received SD-INDO were more premature (p < 0.001) but had lower odds of PDA (OR 0.26 [0.15, 0.44], p < 0.005), PDA receiving treatment (OR 0.12 [0.03, 0.47], p < 0.005), death (OR 0.41 [0.20, 0.86], p = 0.02), and CP severity (OR 0.33 [0.12, 0.89], p = 0.03). There was less IVH (OR 0.58 [0.36, 0.94], p = 0.03) when adjusted for gestational age. Conclusions SD-INDO is associated with decreased PDA and CP severity and improved survival.

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“…An expectative management is gaining interest, although convincing evidence to support this management is lacking, since there is no RCT available comparing treatment with an expectative approach. We found only one small study describing a prospective cohort and several retrospective studies comparing two or three time eras with comparison of different management approaches in preterm infants with a persistent PDA [ 81 – 89 ]. These observational studies have not shown a concomitant increase in mortality and morbidity related to a decrease in active ductal closure.…”

Section: Discussionmentioning

confidence: 99%

“…After analysis of the results from many RCTs it has been concluded that treatment of a PDA does not result in a decreased rate of mortality and morbidity. A conservative approach towards a PDA is increasingly used in many centres worldwide without a concomitant increase in mortality or morbidity [ 51 , 81 – 89 , 95 ]. The administration of IBU in the treatment arm of this trial does not pose an extra burden on the patient as it is considered routine treatment in preterm infants with a PDA in many NICUs.…”

Section: Methodsmentioning

confidence: 99%

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

Hundscheid¹,

Onland

Overmeire

et al. 2018

BMC Pediatr

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BackgroundMuch controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age (GA) less than 28 weeks. No causal relationship has been proven between a (haemodynamically significant) PDA and neonatal complications related to pulmonary hyperperfusion and/or systemic hypoperfusion. Although studies show conflicting results, a common understanding is that medical or surgical treatment of a PDA does not seem to reduce the risk of major neonatal morbidities and mortality. As the PDA might have closed spontaneously, treated children are potentially exposed to iatrogenic adverse effects. A conservative approach is gaining interest worldwide, although convincing evidence to support its use is lacking.MethodsThis multicentre, randomised, non-inferiority trial is conducted in neonatal intensive care units. The study population consists of preterm infants (GA < 28 weeks) with an echocardiographic-confirmed PDA with a transductal diameter > 1.5 mm. Early treatment (between 24 and 72 h postnatal age) with the cyclooxygenase inhibitor (COXi) ibuprofen (IBU) is compared with an expectative management (no intervention intended to close a PDA). The primary outcome is the composite of mortality, and/or necrotising enterocolitis (NEC) Bell stage ≥ IIa, and/or bronchopulmonary dysplasia (BPD) defined as the need for supplemental oxygen, all at a postmenstrual age (PMA) of 36 weeks. Secondary outcome parameters are short term sequelae of cardiovascular failure, comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. Consequences regarding health economics are evaluated by cost effectiveness analysis and budget impact analysis.DiscussionAs a conservative approach is gaining interest, we investigate whether in preterm infants, born at a GA less than 28 weeks, with a PDA an expectative management is non-inferior to early treatment with IBU regarding to the composite outcome of mortality and/or NEC and/or BPD at a PMA of 36 weeks.Trial registrationThis trial is registered with the Dutch Trial Register NTR5479 (registered on 19 October 2015), the 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.

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Effects of therapeutic approach on the neonatal evolution of very low birth weight infants with patent ductus arteriosus

Cited by 4 publications

References 17 publications

Association between endotypes of prematurity and pharmacological closure of patent ductus arteriosus: A systematic review and meta-analysis

Association between endotypes of prematurity and pharmacological closure of patent ductus arteriosus: A systematic review and meta-analysis

Outcomes in infants < 29 weeks of gestation following single-dose prophylactic indomethacin

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

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