Prophylaxis of patent ductus arteriosus using ethamsylate in preterms treated with exogenous surfactant

Amato, Maurizio; Hüppi, PS; Markus, D.

doi:10.1111/j.1651-2227.1992.tb12241.x

Cited by 9 publications

(9 citation statements)

References 11 publications

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“…In this systematic review and meta-analysis, we found only a few perinatal interventions (antenatal corticosteroids, 66,75,76,89,133,157,158,175,197 indomethacin prophylaxis, 23, 24, 46, 57, 92, 108, 127, 147-150, 159, 192, 224, 228 volume-targeted ventilation, 40,52,60,88,116,126,138,139,163,178,179,199,201 early ESAs, 32,68,69,90,107,142,164,169,170,174,203,212 and prophylactic ethamsylate 16,28,39,85,160,189 ) that were associated with decreased risk of sIVH in preterm neonates (Figure 4). The certainty of the evidence for these interventions was low to moderate.…”

Section: Discussionmentioning

confidence: 93%

Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates

et al. 2023

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ImportanceInterventions to reduce severe brain injury risk are the prime focus in neonatal clinical trials.ObjectiveTo evaluate multiple perinatal interventions across clinical settings for reducing the risk of severe intraventricular hemorrhage (sIVH) and cystic periventricular leukomalacia (cPVL) in preterm neonates.Data SourcesMEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception until September 8, 2022, using prespecified search terms and no language restrictions.Study SelectionRandomized clinical trials (RCTs) that evaluated perinatal interventions, chosen a priori, and reported 1 or more outcomes (sIVH, cPVL, and severe brain injury) were included.Data Extraction and SynthesisTwo co-authors independently extracted the data, assessed the quality of the trials, and evaluated the certainty of the evidence using the Cochrane GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Fixed-effects pairwise meta-analysis was used for data synthesis.Main Outcomes and MeasuresThe 3 prespecified outcomes were sIVH, cPVL, and severe brain injury.ResultsA total of 221 RCTs that assessed 44 perinatal interventions (6 antenatal, 6 delivery room, and 32 neonatal) were included. Meta-analysis showed with moderate certainty that antenatal corticosteroids were associated with small reduction in sIVH risk (risk ratio [RR], 0.54 [95% CI, 0.35-0.82]; absolute risk difference [ARD], −1% [95% CI, −2% to 0%]; number needed to treat [NNT], 80 [95% CI, 48-232]), whereas indomethacin prophylaxis was associated with moderate reduction in sIVH risk (RR, 0.64 [95% CI, 0.52-0.79]; ARD, −5% [95% CI, −8% to −3%]; NNT, 20 [95% CI, 13-39]). Similarly, the meta-analysis showed with low certainty that volume-targeted ventilation was associated with large reduction in risk of sIVH (RR, 0.51 [95% CI, 0.36-0.72]; ARD, −9% [95% CI, −13% to −5%]; NNT, 11 [95% CI, 7-23]). Additionally, early erythropoiesis-stimulating agents (RR, 0.68 [95% CI, 0.57-0.83]; ARD, −3% [95% CI, −4% to −1%]; NNT, 34 [95% CI, 22-67]) and prophylactic ethamsylate (RR, 0.68 [95% CI, 0.48-0.97]; ARD, −4% [95% CI, −7% to 0%]; NNT, 26 [95% CI, 13-372]) were associated with moderate reduction in sIVH risk (low certainty). The meta-analysis also showed with low certainty that compared with delayed cord clamping, umbilical cord milking was associated with a moderate increase in sIVH risk (RR, 1.82 [95% CI, 1.03-3.21]; ARD, 3% [95% CI, 0%-6%]; NNT, −30 [95% CI, −368 to −16]).Conclusions and RelevanceResults of this study suggest that a few interventions, including antenatal corticosteroids and indomethacin prophylaxis, were associated with reduction in sIVH risk (moderate certainty), and volume-targeted ventilation, early erythropoiesis-stimulating agents, and prophylactic ethamsylate were associated with reduction in sIVH risk (low certainty) in preterm neonates. However, clinicians should carefully consider all of the critical factors that may affect applicability in these interventions, including certainty of the evidence, before applying them to clinical practice.

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Section: Discussionmentioning

confidence: 93%

Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates

et al. 2023

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“…Rosti et al 29 (1994) found that ethamsylate reduced the incidence of PDA from 25% to 1%. A well-designed clinical trial by Amato et al 30 confirmed the efficacy of ethamsylate on PDA in very low birth weight infants treated with exogenous surfactant.…”

Section: Periventricular Hemorrhage In Very Low Birth Weight Babiesmentioning

confidence: 84%

Therapeutic Efficacy and Mechanism of Action of Ethamsylate, a Long-Standing Hemostatic Agent

Garay¹,

Chiavaroli²,

Hannaert

2006

American Journal of Therapeutics

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Ethamsylate (2,5-dihydroxy-benzene-sulfonate diethylammonium salt) is a synthetic hemostatic drug indicated in cases of capillary bleeding. This review covers more than 40 years of intensive clinical and fundamental research with ethamsylate. First, we summarize the large medical literature concerning its clinical efficacy. Of these, well-controlled clinical trials clearly showed the therapeutic efficacy of ethamsylate in dysfunctional uterine bleeding, with the magnitude of blood-loss reduction being directly proportional to the severity of the menorrhagia. Other well-controlled clinical trials showed therapeutic efficacy of ethamsylate in periventricular hemorrhage in very low birth weight babies and surgical or postsurgical capillary bleeding. Second, we review the numerous investigations performed to elucidate the mechanism of action of ethamsylate. Ethamsylate acts on the first step of hemostasis by improving platelet adhesiveness and restoring capillary resistance. Recent studies showed that ethamsylate promotes P-selectin-dependent, platelet adhesive mechanisms. Finally, we compare ethamsylate with other recent hemostatic agents. It is suggested that the place of ethamsylate as a hemostatic agent is that of a mild but well-tolerated drug, particularly useful in dysfunctional uterine bleeding when contraception is not needed.

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“…Meta‐analysis from randomized controlled trials (RCTs) of nonsteroidal antiinflammatory drugs (NSAID) treatment trials for PDA in preterm infants show that treatment is quite effective in causing closure of the ductus in preterm infants. The pooled odds ratio for persistent ductal patency after NSAID treatment based on 56 reports of RCTs involving 5747 patients was 0.23 [95% confidence interval (CI): 0.21‐0.26] (Figure) . Even though this meta‐analysis included 4 different drugs administered by at least 2 different routes for three different categories of indications, as well as surgical ligation, subgrouping based on any of these variables showed equivalent results.…”

Section: Randomized Trials Of Treatment To Achieve Ductal Closurementioning

confidence: 92%

PDA: To treat or not to treat

Bhombal

Benitz

2019

Congenital Heart Disease

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Management of patent ductus arteriosus in extremely preterm infants remains a topic of debate. Treatment to produce ductal closure was widely practiced until the past decade, despite lack of evidence that it decreases morbidities or mortality. Meta‐analyses of trials using nonsteroidal anti‐inflammatory drugs have shown effectiveness in accelerating ductal closure, but no reduction in neonatal morbidities, regardless of agent used, indication, timing, gestational age, or route of administration. Surgical ligation closes the ductus but is associated with adverse effects. Recent experience with conservative approaches to treatment suggest improved neonatal outcomes and a high rate of spontaneous ductal closure after discharge. Careful postdischarge follow‐up is important, however, because potential adverse effects of long‐standing aortopulmonary shunts may be an indication for catheter‐based ductal closure. Identification of extremely preterm infants at greatest risk of potential harm from a persistently patent ductus, who may benefit most from treatment are urgently needed.

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Prophylaxis of patent ductus arteriosus using ethamsylate in preterms treated with exogenous surfactant

Cited by 9 publications

References 11 publications

Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates

Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates

Therapeutic Efficacy and Mechanism of Action of Ethamsylate, a Long-Standing Hemostatic Agent

PDA: To treat or not to treat

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