Dataset Information

Surgical management of patent ductus arteriosus in pre-term infants - a british paediatric surveillance study.

ABSTRACT:

Background

This study aimed to provide UK data describing the incidence of patent ductus arteriosus (PDA) surgery in the neonatal population, including: pre-ligation management, and outcomes until discharge. We used British Paediatric Surveillance Unit (BPSU) methodology; collecting data via questionnaires for preterm neonates undergoing PDA ligation (PDAL) between 1st Sept 2012 - 30th Sept 2013. Infants born less than 37 weeks gestation, who underwent PDAL prior to discharge home, with no other structural cardiac abnormality, were included. Information collected included: patient demographics, pre and post-operative clinical characteristics, pre-operative medical management, post-operative complications and outcome.

Results

Over the study, 263 infants underwent PDAL an incidence of 3.07 per 10,000 live births. 88% were born extremely preterm (< 28 weeks) and 60% were male. The commonest reasons for ligation were inability to wean respiratory support (83.7%) and haemodynamically significant PDA (87.8%). Pre-operatively 65.7% received medical therapy. Surgery was performed at a median age of 33 days (range 9-260, IQR 24-48); the corrected age was less than 31 + 6 week in 50.6% babies at PDAL. Most, (90%), of procedures were open ligation; only 9 (3.4%) were catheter occlusions (PDACO). 20.5% of patients had post-operative complications. The 30-day mortality was 3%, with 93.5% surviving to hospital discharge.

Conclusion

This study showed there was little consensus over medical and surgical management of the PDA or timing of surgery.

SUBMITTER: Warnock A

PROVIDER: S-EPMC8187455 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSymptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored.ObjectivesTo determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA.Search methodsWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.Selection criteriaWe included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants.Data collection and analysisWe used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding.Main resultsWe included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision.Authors' conclusionsHigh-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.