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5 th International Workshop on Neonatology The Future of European Neonatology Cagliari, October 30-31, 2009 Non Steroids Anti-inflammatory Drugs in the.

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Presentation on theme: "5 th International Workshop on Neonatology The Future of European Neonatology Cagliari, October 30-31, 2009 Non Steroids Anti-inflammatory Drugs in the."— Presentation transcript:

1 5 th International Workshop on Neonatology The Future of European Neonatology Cagliari, October 30-31, 2009 Non Steroids Anti-inflammatory Drugs in the treatment of PDA in European Newborns Hercília Guimarães On the behalf of the Collaborative Study

2 NSAIDs to treat PDA in European Newborns Introduction I PDA is a common cause of morbidity and mortality among VLBW infants. The clinical decision of treating PDA should be carried out on an individual basis, according to the clinical condition of the newborn, its hemodynamic importance and potential risks. Echocardiographic evaluation is necessary to establish the diagnosis and to follow the treatment.


4 NSAIDs to treat PDA in European Newborns Introduction II Indomethacin and ibuprofen, NSAIDs, used in the treatment of PDA in preterm newborn infants have been shown to produce closure in approximately 85% of patients. The choice for Indomethacin or Ibuprofen should be established after evaluation of the clinical condition, costs and local or regional availability

5 NSAIDs to treat PDA in European Newborns Aim To know the European reality on NSAIDs in the treatment of PDA in preterm newborns.

6 NSAIDs to treat PDA in European Newborns Material and Methods A questionnaire to be filled was sent to: Presidents of the 24 European Societies of Neonatology/ Perinatology (UENPS) and 3 representatives NICUs in Europe ( UK, Belgium, Germany)

7 NSAIDs in the treatment of PDA in European newborns Questionnaire Country and NICU What drugs do you use in your country to treat PDA? Ibuprofen (iv) No ____Yes ____ Doses _________ Ibuprofen (oral) No ____Yes ____ Doses _____________ Indomethacin (iv) No ____Yes ____ Doses____________ Indomethacin (iv) Perfusion 30 min_____ 60 min__________ Others_________________ How many courses of treatment do you use? 1___ 2 ____3______ Do you use prolonged treatment? No __ Yes_____ Doses ____ How many days? ____ In which babies?______ Why do you prefer ibuprofen ? ______________________________ Why do you prefer indomethacin ? _____________________ When do you use NSAIDs? Prophylactic treatment No________ Yes___________ PDA no hemodynamically significant No_______Yes ___________ PDA hemodynamically significant No________ Yes __________ Do you use fluid restriction with NSAIDs ? No___ Yes __ If yes, how much (ml/kg) __________ Do you stop oral feeding during NSAIDs ? No_____ Yes ______ Do you use diuretics: No_____ Yes ____Which?_____ Do you diagnose PDA on a clinical basis only ? No________ Yes ________ Do you diagnose PDA by echocardiography ? No________ Yes ________ Which echocardiography criteria do you use to PDA hemodinamically significant: Ductal diameter of >1.4mm No___ Yes ________ Left atrial:aortic root >1.3:1 No________ Yes _______ Retrograde diastolic flow in descending aorta exceeding 30% of anterograde flow: No__Yes __ Other criteria_________________ Do you monitor PDA by echo ? No___ Yes____ Examinations during a course__________________

8 NSAIDs in the treatment of PDA in European newborns Questionnaire What contra-indications do you consider to NSAIDs treatment? Indomethacin Ibuprofen Platelets < 25.000 Creat. > 2.5 mg/dl (or >___) Oliguria NEC HIV Bleeding Others When do you propose surgical closure of PDA? 1. After failure of : 1___ 2__ 3 ___ 4______ courses of treatment 2.After 3 weeks of life No ___ Yes _____ 3.Before 3 weeks of life No ____ Yes___ 4. In babies < 1000g No ____ Yes ____ 5. Contra-indications to medical treatment No_____ Yes___ Please Indicate Ibuprofen solution__________________________________ Are your choices influenced by Administration economical reasons? Number of babies with PDA / year in your NICU?__________________ Number of Admission / year in your Unit?__________________________ Number of Admission / year of VLBW in your Unit?_________________ Comments

9 NSAIDs to treat PDA in European Newborns Results 45 NICUs from 19 countries filled the questionnaire: 1 (2 %) - North 26 (58 %) - South 12 (27 %) - East 6 (13 %) - West


11 Number of admissions, VLBW infants and PDA / year n=45 Mean SD Median (min – max) Admissions 441+234372 (125–1300) VLBW infants 102+9081 (4–550) PDA 38+3130 (2–150) % PDA/ admissions 9+ 69 (0.4–25) % PDA/ VLBW infants 41+2039 (3–100) PDA= patent ductus arteriosus; VLBW infants

12 NSAIDs to treat PDA in the European newborns n=45 n (%)Number of doses Ibuprofen intravenous oral rectal 16 (36) 13 (29) 1 (2) 3 3* Indomethacin intravenous intramuscular 32 (71) 1 (2) 3** 1 NICU does not use NSAIDs; 2 NICUs use prolonged treatment in all cases; * 2 NICUs use 2 doses; ** 3 NICUs use 4 and 5 doses

13 Indomethacin and Ibuprofen The perfusion of Indomethacin is done during : 30 minutes in 20 (63%) NICUs 60 minutes in 8 (25%) 20 minutes in one. The number of treatment courses used is : 2 in 20 (45 %) NICUs 3 in 12 (27 %) NICUs more than 3 courses in 2 1 NICU uses 2 courses of Ibuprofen + 1of Indomethacin

14 Indomethacin and Ibuprofen Prolonged treatment (4-6 days) was mentioned by 20 (45%) NICUs. The selected newborns to prolonged treatment are: failure of 3 treatment courses in 7 (35 %) < 1500g in 6 (30 %) < 1000g in 3 (15 %) all babies in 2 critical conditions in 1 Ibuprofen failure in 1

15 Indomethacin and Ibuprofen Prophylactic treatment is used in 2 NICUs 11 (25%) treat no hemodynamically significant PDA 43 (98%) treat hemodynamically significant PDA. 1 NICU uses surgical closure as first line treatment.

16 Indomethacin and Ibuprofen Fluid restriction during NSAIDs treatment in 36 (80%) NICUs the percentage of restriction is 20% in 9 NICUs and 30% in 5. 9 (20%) NICUs stop oral feeding during NSAIDs treatment. Diuretics are used in 22 (49%) NICUs: furosemide in 19 (86%) furosemide and/or spironolactone in 3 (+ NSAIDs)

17 Indomethacin and Ibuprofen The diagnosis of PDA is confirmed by echocardiography in all NICUs. The echocardiographic criteria of hemodynamically significant PDA are: ductal diameter >1.4mm in 28 (64%) NICUs; left atrial:aortic root >1.3:1 in 31 (70%); retrograde diastolic flow in desc. aorta>30% of anterograde flow in 24 (55%) 15 (34 %) use other criteria. 37(82%) NICUs monitor PDA by echocardiography.

18 Indomethacin and Ibuprofen Surgical closure of PDA is proposed : after failure of 1, in 2 (5 %), 2, in 20 (45 %), and >3, and 12 (27 %) NICUs after 3 weeks of life in 24 (53 %) before 3 weeks of life in 12 (27 %) in babies < 1000g, in 17 (39%) contra-indications to NSAIDs in 27 (61 %)

19 Indomethacin and Ibuprofen Pedea R is the iv Ibuprofen solution used Ibuprofen oral solution has a concentration of 20mg/ml.

20 Contra-indications for NSAIDs treatment Indomethacin (n=33), n (%) Ibuprofen (n=30), n (% Platelets < 25.000 231* (94)24* (80) Creatinine 2.5 mg/dl 22** (67)18*** (60) Oligury 33 (100)16 (53) NEC 33 (100)24 (80) IVH 19 (58)13 (43) Bleeding (active) 30 (91)22 (73) Others ETcriteria heart failure infection 1 (3) 2 (7) 1 (3) *1 NICU uses 1.5 mg/dl and 1 NICU uses > 1.8 mg/dl; *** 2 NICUs use > 1.5 mg/dl

21 Indomethacin and Ibuprofen preference Indomethacin (n=33), n (%) Ibuprofen (n=30), n (%) Safety 2 (6)15 (50) Effectiveness 4 (12)3 (10) Cost 10 (30)6* (20) Experience 12** (36)4*** (13) * oral Ibuprofen; ** only Indomethacin was available in 5 NICUs ; *** only oral Ibuprofen was available

22 Indomethacin and Ibuprofen The choices are influenced by economical reasons in 10 (22%) NICUs.

23 NSAIDs to treat PDA in European Newborns Conclusion Our data show a wide variation among NICUs and countries regarding the use of NSAIDs to treat PDA and no general guidelines are followed. Guidelines or recommendations are necessary to treat PDA in Europe, giving all newborns identical health care opportunities.


25 Collaborators Belgium: B. van Overmeire, University of Antwerp. Bósnia and Herzegovinia: S. Heljic, Clinical University Sarajevo; S. Bajic, Cardiology, Clinical Centre Banja Luka. Bulgary: N. Jekova, Neonatology, Specialized Hospital of Obstetrics and Gynecology "Maichin dom", Sofia. Croatia: Emilja Ejuretic,NICU Clinical Hospital Zagreb. Estonia: Tuuli Metsvaht, Tartu Paediatric and Neonatal Intensive. France: P-H. Jarreau, Port-Royal, Paris; J.C. Picaud, Hôpital de la Croix Rouge, Lyon. Germany: A.Franz, University of Tuebingen. Greece: F. Anatolitou, Agia Sophia Children Hospital, Athens; K. Sarafidis, Hippokration General Hospital, Thessaloniki; Andreou A Hippokration, General Hospital Thessaloniki; Mitsiakos G. Papageorgiou, General Hospital Thessaloniki; Mousafiris K, Interbalcan Medical Center Thessaloniki; Galanopoulou A., Agios Andreas Hospital, Patras; Sigalas I, University General Hospital Alexandroupolis; Andronikou S, University Hospital of Ioannina; Papadimitriou M, Aglaia Kyraikou Children Hospital, Athens; Siokou E, Lito Maternity Hospital Athens, Kostantinou D, Iaso Maternity Hospital, Athens Gounaris A, Nikaia General Hospital, Piraeus. Hungary: T. Kovacs, Medical and Health Science Center, Debrecen.

26 Collaborators Italy: V. Fanos, Neonatal Intensive Care Unit, University of Cagliari; M. Pusceddu, Cesena. Macedonia: K.Piperkova. Netherlands: J.B. van Goudoever, Erasmus MC/Sophia Children's Hospital, Rotterdam. Portugal: A.Freitas, Hospital Senhora da Oliveira, Guimarães; E. Proença, Maternidade Júlio Dinis, Porto; A. Pereira, Hospital de S. Marcos, Braga; A. Salazar, Hospital S. Francisco Xavier, Lisboa; D. Virella, Hospital d. Estefânia, Lisboa; H. Guimarães, G. Rocha, São João Hospital, Porto University; T. Tomé, Maternidade Alfredo da Costa, Lisboa; S. Pedro Frutuoso, Hospital de Santo António, Porto; G. Mimoso, Maternidade Bissaya Barreto, Coimbra. Romania: S. Silvia, Bucharest; Tg- Mures; Iasi. Spain: M. Sanchez-Luna, Gregorio Maragnon Hospital, Madrid; J. Pérez, La Paz Hospital, Madrid. Slovakia: F. Bauer, Nové Zámky; M. Zibolen, University Hospital Martin; Slovenia: J. Babnik, University Medical Centre, Ljubjana. Turkey: M. Yurdakok, Hacettepe University, Istanbul. United Kingdom: N. Modi, Imperial College, London.

27 Thank you very much for your atention

28 Porto and River Douro

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