Survey highlighting the lack of consensus on diagnosis and treatment of patent ductus arteriosus in prematurity.
Conservative approach
Ibuprofen
Morbidity
Mortality
PDA
Placebo
Journal
European journal of pediatrics
ISSN: 1432-1076
Titre abrégé: Eur J Pediatr
Pays: Germany
ID NLM: 7603873
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
12
07
2021
accepted:
09
03
2022
revised:
08
03
2022
pubmed:
20
3
2022
medline:
19
5
2022
entrez:
19
3
2022
Statut:
ppublish
Résumé
To gain insight in the availability of guidelines, diagnostic criteria, and treatment strategies and whether clinical equipoise regarding optimal treatment for patent ductus arteriosus (PDA) in prematurity is present. We hypothesized that (co-)authors of PDA-related papers were more likely to screen for a PDA and would treat earlier and more aggressively. An international internet-based survey between September 2019 and March 2020 in which we collected (1) baseline characteristics; (2) availability of guidelines; (3) screening strategy for PDA; (4) diagnostic criteria for hemodynamic significance; (5) treatment strategy; and (6) metrics of treatment efficacy. Finally, ten clinical equipoise statements were posed on a Likert scale. In total, 144 surveys were sent, of which 71/144 (49%) surveys could be analyzed with 56/71 (79%) fully completed surveys. The respondents, mainly neonatologists in a level III neonatal intensive care unit, of whom 36/71 (51%) had (co-)authored a publication on the PDA, highlighted a lack of national guidelines, heterogeneous approach to screening strategies, and marked variability in diagnostic criteria to assess hemodynamic significance, treatment strategies and effect measurement. No major significant differences were observed between respondents who did or did not (co-)author a publication on the PDA. Respondents who screened for PDA scored significantly higher on the need for screening, early and aggressive treatment. Remarkably, the scores of all statements regarding clinical equipoise varied widely. Conclusions: Our survey highlights the lack of guidelines and enormous heterogeneity in current practice. Current evidence is not robust enough to harmonize current treatment strategies into (inter)national guidelines. What is Known: • Patent ductus arteriosus (PDA) incidence is inversely related to gestational age. • Although early pharmacological treatment induces PDA closure, optimal treatment is debated due to the lack of beneficial effects on outcome. What is New: • In the absence of (inter)national guidelines, diagnostic and treatment strategies are heterogeneous and contradictory, even in a selected hemodynamically- interested group. • Different PDA screening strategies did, while PDA publication status did not, show significant differences in treatment strategy and responses to equipoise statements.
Identifiants
pubmed: 35305143
doi: 10.1007/s00431-022-04441-8
pii: 10.1007/s00431-022-04441-8
pmc: PMC9110525
doi:
Substances chimiques
Ibuprofen
WK2XYI10QM
Indomethacin
XXE1CET956
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2459-2468Informations de copyright
© 2022. The Author(s).
Références
Mitra S, Florez ID, Tamayo ME, Mbuagbaw L, Vanniyasingam T, Veroniki AA, Zea AM, Zhang Y, Sadeghirad B, Thabane L (2018) Association of placebo, indomethacin, ibuprofen, and acetaminophen with closure of hemodynamically significant patent ductus arteriosus in preterm infants: a systematic review and meta-analysis. JAMA 319(12):1221–1238. https://doi.org/10.1001/jama.2018.1896
doi: 10.1001/jama.2018.1896
pubmed: 29584842
pmcid: 5885871
Hundscheid T, Onland W, van Overmeire B, Dijk P, van Kaam A, Dijkman KP, Kooi EMW, Villamor E, Kroon AA, Visser R, Vijlbrief DC, de Tollenaer SM, Cools F, van Laere D, Johansson AB, Hocq C, Zecic A, Adang E, Donders R, de Vries W, van Heijst AFJ, de Boode WP (2018) Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial). BMC Pediatr 18(1):262. https://doi.org/10.1186/s12887-018-1215-7
doi: 10.1186/s12887-018-1215-7
pubmed: 30077184
pmcid: 6090763
Jansen EJS, Hundscheid T, Onland W, Kooi EMW, Andriessen P, de Boode WP (2021) Factors associated with benefit of treatment of patent ductus arteriosus in preterm infants: a systematic review and meta-analysis. Front Pediatr 9(45). https://doi.org/10.3389/fped.2021.626262
Ngo S, Profit J, Gould JB, Lee HC (2017) Trends in patent ductus arteriosus diagnosis and management for very low birth weight infants. Pediatrics 139(4):e20162390. https://doi.org/10.1542/peds.2016-2390
Harkin P, Harma A, Aikio O, Valkama M, Leskinen M, Saarela T, Hallman M (2016) Paracetamol accelerates closure of the ductus arteriosus after premature birth: a randomized trial. J Pediatr 177(72–77):e72. https://doi.org/10.1016/j.jpeds.2016.04.066
doi: 10.1016/j.jpeds.2016.04.066
Hochwald O, Mainzer G, Borenstein-Levin L, Jubran H, Dinur G, Zucker M, Mor M, Khoury A, Kugelman A (2018) Adding paracetamol to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: a double-blind, randomized, placebo-controlled pilot study. Am J Perinatol 35(13):1319–1325. https://doi.org/10.1055/s-0038-1653946
doi: 10.1055/s-0038-1653946
pubmed: 29783269
Zonnenberg I, de Waal K (2012) The definition of a haemodynamic significant duct in randomized controlled trials: a systematic literature review. Acta Paediatr 101(3):247–251. https://doi.org/10.1111/j.1651-2227.2011.02468.x
doi: 10.1111/j.1651-2227.2011.02468.x
pubmed: 21913976
Babla K, Duffy D, Dumitru R, Richards J, Kulkarni A (2021) Repeatability of PDA diameter measurements on echocardiography. Eur J Pediatr. https://doi.org/10.1007/s00431-021-04178-w
doi: 10.1007/s00431-021-04178-w
pubmed: 34184120
El-Khuffash A, James AT, Corcoran JD, Dicker P, Franklin O, Elsayed YN, Ting JY, Sehgal A, Malikiwi A, Harabor A, Soraisham AS, McNamara PJ (2015) A patent ductus arteriosus severity score predicts chronic lung disease or death before discharge. J Pediatr 167(6):1354–136 e1352. https://doi.org/10.1016/j.jpeds.2015.09.028
doi: 10.1016/j.jpeds.2015.09.028
pubmed: 26474706
Rios DR, Martins FdF, El-Khuffash A, Weisz DE, Giesinger RE, McNamara PJ (2021) Early role of the atrial-level communication in premature infants with patent ductus arteriosus. J Am Soc Echocardiogr 34(4):423–432.e1. https://doi.org/10.1016/j.echo.2020.11.008
doi: 10.1016/j.echo.2020.11.008
pubmed: 33227390
Castor EDC (2019) Castor electronic data capture. https://castoredc.com . Accessed 28 Aug 2019
Burns KE, Duffett M, Kho ME, Meade MO, Adhikari NK, Sinuff T, Cook DJ (2008) A guide for the design and conduct of self-administered surveys of clinicians. CMAJ 179(3):245–252. https://doi.org/10.1503/cmaj.080372
doi: 10.1503/cmaj.080372
pubmed: 18663204
pmcid: 2474876
Eysenbach G (2004) Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res 6(3):e34. https://doi.org/10.2196/jmir.6.3.e34
doi: 10.2196/jmir.6.3.e34
pubmed: 15471760
pmcid: 1550605
Academy of Pediatrics Committee on Fetus and Newborn (2012) Levels of neonatal care. Pediatrics 130(3):587–597. https://doi.org/10.1542/peds.2012-1999
doi: 10.1542/peds.2012-1999
McNamara PJ, Sehgal A (2007) Towards rational management of the patent ductus arteriosus: the need for disease staging. Arch Dis Child Fetal Neonatal Ed 92(6):F424-427. https://doi.org/10.1136/adc.2007.118117
doi: 10.1136/adc.2007.118117
pubmed: 17951547
pmcid: 2675381
Sathanandam S, Whiting S, Cunningham J, Zurakowski D, Apalodimas L, Waller BR, Philip R, Qureshi AM (2019) Practice variation in the management of patent ductus arteriosus in extremely low birth weight infants in the United States: survey results among cardiologists and neonatologists. Congenit Heart Dis 14(1):6–14. https://doi.org/10.1111/chd.12729
doi: 10.1111/chd.12729
pubmed: 30811803
Evans P, O’Reilly D, Flyer JN, Soll R, Mitra S (2021) Indomethacin for symptomatic patent ductus arteriosus in preterm infants. Cochrane Database Syst Rev 1(1):Cd013133. https://doi.org/10.1002/14651858.CD013133.pub2
Dowd LA, Wheeler BJ, Al-Sallami HS, Broadbent RS, Edmonds LK, Medlicott NJ (2019) Paracetamol treatment for patent ductus arteriosus: practice and attitudes in Australia and New Zealand. J Matern Fetal Neonatal Med 32(18):3039–3044. https://doi.org/10.1080/14767058.2018.1456520
doi: 10.1080/14767058.2018.1456520
pubmed: 29562792
Juujärvi S, Saarela T, Hallman M, Aikio O (2021) Trial of paracetamol for premature newborns: five-year follow-up. J Matern Fetal Neonatal Med 1–3. epub ahead of print https://doi.org/10.1080/14767058.2021.1875444
Dani C, Lista G, Bianchi S, Mosca F, Schena F, Ramenghi L, Zecca E, Vento G, Poggi C, Leonardi V, Minghetti D, Rosignoli MT, Calisti F, Comandini A, Cattaneo A, Lipone P (2020) Intravenous paracetamol in comparison with ibuprofen for the treatment of patent ductus arteriosus in preterm infants: a randomized controlled trial. Eur J Pediatr. https://doi.org/10.1007/s00431-020-03780-8
doi: 10.1007/s00431-020-03780-8
pubmed: 33083899
pmcid: 7886841
van den Anker JN, Allegaert K (2016) Acetaminophen to prevent symptomatic patent ductus arteriosus: another drug bites the dust?. J Pediatr 177:7–9. https://doi.org/10.1016/j.jpeds.2016.06.034
doi: 10.1016/j.jpeds.2016.06.034
pubmed: 27448839
van den Anker JN, Allegaert K (2018) Acetaminophen in the neonatal intensive care unit: shotgun approach or silver bullet. J Pediatr 198:10–11. https://doi.org/10.1016/j.jpeds.2018.02.046
doi: 10.1016/j.jpeds.2018.02.046
pubmed: 29605390
Clyman RI, Liebowitz M, Kaempf J, Erdeve O, Bulbul A, Hakansson S, Lindqvist J, Farooqi A, Katheria A, Sauberan J, Singh J, Nelson K, Wickremasinghe A, Dong L, Hassinger DC, Aucott SW, Hayashi M, Heuchan AM, Carey WA, Derrick M, Fernandez E, Sankar M, Leone T, Perez J, Serize A, Investigators P-TT (2019) PDA-TOLERATE Trial: an exploratory randomized controlled trial of treatment of moderate-to-large patent ductus arteriosus at 1 week of age. J Pediatr 205(41–48):e46. https://doi.org/10.1016/j.jpeds.2018.09.012
doi: 10.1016/j.jpeds.2018.09.012
Noureldein M, Hu K, Groucutt J, Heaver R, Gurusamy K (2020) Paracetamol for patent ductus arteriosus in preterm infants: a UK national survey. J Matern Fetal Neonatal Med 1–4. https://doi.org/10.1080/14767058.2020.1752652
Benitz WE (2016) Patent ductus arteriosus in preterm infants. Pediatrics 137(1). https://doi.org/10.1542/peds.2015-3730
Mitra S, Scrivens A, von Kursell AM, Disher T (2020) Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev 12:Cd013278. https://doi.org/10.1002/14651858.CD013278.pub2
van Laere D, van Overmeire B, Gupta S, El-Khuffash A, Savoia M, McNamara PJ, Schwarz CE, de Boode WP (2018) Application of NPE in the assessment of a patent ductus arteriosus. Pediatr Res 84(Suppl 1):46–56. https://doi.org/10.1038/s41390-018-0077-x
doi: 10.1038/s41390-018-0077-x
pubmed: 30072803
pmcid: 6257219
Broadhouse KM, Price AN, Durighel G, Cox DJ, Finnemore AE, Edwards AD, Hajnal JV, Groves AM (2013) Assessment of PDA shunt and systemic blood flow in newborns using cardiac MRI. NMR Biomed 26(9):1135–1141. https://doi.org/10.1002/nbm.2927
doi: 10.1002/nbm.2927
pubmed: 23412748
Carmo KB, Evans N, Paradisis M (2009) Duration of indomethacin treatment of the preterm patent ductus arteriosus as directed by echocardiography. J Pediatr 155(6):819–822.e811. https://doi.org/10.1016/j.jpeds.2009.06.013
doi: 10.1016/j.jpeds.2009.06.013
pubmed: 19643435
Bravo MC, Cabañas F, Riera J, Pérez-Fernández E, Quero J, Pérez-Rodríguez J, Pellicer A (2014) Randomised controlled clinical trial of standard versus echocardiographically guided ibuprofen treatment for patent ductus arteriosus in preterm infants: a pilot study. J Matern Fetal Neonatal Med 27(9):904–909. https://doi.org/10.3109/14767058.2013.846312
doi: 10.3109/14767058.2013.846312
pubmed: 24047189
Su BH, Peng CT, Tsai CH (1999) Echocardiographic flow pattern of patent ductus arteriosus: a guide to indomethacin treatment in premature infants. Arch Dis Child Fetal Neonatal Ed 81(3):F197–200. https://doi.org/10.1136/fn.81.3.f197
doi: 10.1136/fn.81.3.f197
pubmed: 10525023
pmcid: 1721002
Garland J, Buck R, Weinberg M (1994) Pulmonary hemorrhage risk in infants with a clinically diagnosed patent ductus arteriosus: a retrospective cohort study. Pediatrics 94(5):719–723
doi: 10.1542/peds.94.5.719
Sehgal A, Mak W, Dunn M, Kelly E, Whyte H, McCrindle B, McNamara PJ (2010) Haemodynamic changes after delivery room surfactant administration to very low birth weight infants. Arch Dis Child Fetal Neonatal Ed 95(5):F345–351. https://doi.org/10.1136/adc.2009.173724
doi: 10.1136/adc.2009.173724
pubmed: 20538711
Sung SI, Lee MH, Ahn SY, Chang YS, Park WS (2020) Effect of nonintervention vs oral ibuprofen in patent ductus arteriosus in preterm infants: a randomized clinical trial. JAMA Pediatr. https://doi.org/10.1001/jamapediatrics.2020.1447
doi: 10.1001/jamapediatrics.2020.1447
pubmed: 32832975
pmcid: 7445628
Bell JL, Gupta S, Juszczak E, Hardy P, Linsell L (2021) Baby-OSCAR: outcome after selective early treatment for closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes. Trials 22(1):368. https://doi.org/10.1186/s13063-021-05324-3
doi: 10.1186/s13063-021-05324-3
pubmed: 34039414
pmcid: 8157743
Hundscheid T, Donders R, Onland W, Kooi EMW, Vijlbrief DC, de Vries WB, Nuytemans DHGM, van Overmeire B, Mulder AL, de Boode WP, Dijk PH, van Kaam AHLC, de Baat T, Dijkman KP, Villamor E, Kroon AA, Visser R, de Tollenaer SM, Cools F, Meeus M, Johansson A-B, Derriks F, Hocq C, Zecic A, Henriksen TB, Kyng KJ, on behalf of the BeNeDuctus trial study g (2021) 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 22(1):627. https://doi.org/10.1186/s13063-021-05594-x
doi: 10.1186/s13063-021-05594-x
pubmed: 34526095
pmcid: 8444433
Shah SD, Makker K, Nandula P, Smotherman C, Kropf A, Hudak ML (2021) Effectiveness of dual medication therapy (oral acetaminophen and oral ibuprofen) for the management of patent ductus arteriosus in extremely premature infants: a feasibility trial. Am J Perinatol. https://doi.org/10.1055/s-0040-1722329
doi: 10.1055/s-0040-1722329
pubmed: 34729719
Hundscheid T, Jansen EJS, Onland W, Kooi EMW, Andriessen P, de Boode WP (2021) Conservative management of patent ductus arteriosus in preterm infants–a systematic review and meta-analyses assessing differences in outcome measures between randomized controlled trials and cohort studies. Front Pediatr 9(44). https://doi.org/10.3389/fped.2021.626261
Fraisse A, Bautista-Rodriguez C, Burmester M, Lane M, Singh Y (2020) Transcatheter closure of patent ductus arteriosus in infants with weight under 1,500 grams. Front Pediatr 8:558256. https://doi.org/10.3389/fped.2020.558256
doi: 10.3389/fped.2020.558256
pubmed: 33072674
pmcid: 7536298