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Titolo:
THERAPY OF NEONATAL RESPIRATORY-DISTRESS SYNDROME (NRDS) BY ALVEOFACT(R) - RESULTS OF A PROSPECTIVE OBSERVATIONAL STUDY
Autore:
WAUER RR; SCHMALISCH G; ROGALSKI M; SCHROTER L; DARR; KAMRAD; ERLER; REUTER M; ARAND; BUCHENAU; JAHRIG D; RAPPSILBER; VOGTMANN; ABEL; LAMME; HUBSCHMANN H; WUCHNER U; ZINK; EDELMANN; WILLE B; PAWLOWSKI; JACOBY; SCHUTTAUF; FUNKE; RUHE B; BERG; SCHMIDTROSSIN; RAITH; WEBER; SITKA; KLAUBE; THUMMLER; HOCK; SAUR; HOHMANN; HOLTGE; JANSEN; LUTTICKE B; LAWRENZWOLF; LEONHARDT; HULTZSCH; RINSCHEN; JOHN; HAUTZ; BETUCH; JESCHE P; FAUST; FERRARI; KESSLER; DIETRICH; BRAND; BOHMANN; SCHARNETZKY;
Indirizzi:
HUMBOLDT UNIV BERLIN,KLINIKUMS CHARITE,KINDERKLIN,KLIN & POLIKLIN KINDERHEILKUNDE,ABT NEONATOL D-10098 BERLIN GERMANY KRANKENHAUS FRIEDRICHSHAIN,KINDERKLIN BERLIN GERMANY UNIV KLINIKUM CHARITE,KINDERKLIN BERLIN GERMANY KLIN KINDER & JUGENDMED,NEONATOL ZENTRUM FRANKFURT GERMANY STADT KLINIKEN CHEMNITZ,SAUGLINGSKLIN CHEMNITZ GERMANY CARL THIEM KLINKUM COTTBUS,KINDERKLIN COTTBUS GERMANY STADT KLINIKEN DESSAU,KINDERKLIN DESSAU GERMANY AKAD KINDERKLIN DRESDEN DRESDEN GERMANY AKAD KINDERKLIN ERFURT ERFURT GERMANY UNIV KINDERKLIN GREIFSWALD GREIFSWALD GERMANY UNIV KINDERKLIN JENA JENA GERMANY UNIV KINDERKLIN LEIPZIG LEIPZIG GERMANY AKAD KINDERKLIN MAGDEBURG MAGDEBURG GERMANY KINDERKLIN POTSDAM POTSDAM GERMANY KINDERKLIN NEUBRANDENBURG NEUBRANDENBURG GERMANY AGR KRANKENHAUS KINDERKLIN SAALFELDT SAALFELDT GERMANY KINDERKLIN SUHL SUHL GERMANY KLINIKUM SCHWERIN,KINDERKLIN SCHWERIN GERMANY STADT KRANKENHAUS WISMAR,ABT NEONATOL WISMAR GERMANY HEINRICH BRAUN KRANKENHAUS,KINDERKLIN ZWICKAW GERMANY DRK KRANKENHAUS CHEMNITZ RABENSTEIN,KINDERABT CHEMNITZ GERMANY KRANKENHAUS NEUKOLLN,KINDERKRANKENHAUS BERLIN GERMANY KREISKRANKENHAUS DETMOLD,KINDER & JUGENDMED KLIN DETMOLD GERMANY STADT KRANKENHAUS HILDESHEIM,KINDERABT HILDESHEIM GERMANY KINDERKLIN FULDA FULDA GERMANY UNIV KINDERKLIN HALLE,ABT NEONATOL HALLE GERMANY ST BARBARA KRANKENHAUS,KINDERABT HALLE GERMANY KLINIKUM BERLIN,KINDERKLIN BERLIN 2 BERLIN GERMANY KINDERABT KREISKRANKENHAUS AALEN GERMANY KREISKRANKENHAUS,KINDERKLIN OLDENBURG GERMANY EV DIAKONISSENANSTALT KINDERKRANKENHAUS WAIBLINGEN GERMANY ST HEDWIG KRANKENHAUS,KINDERABT FREIBURG FREIBURG GERMANY STADT KLINIKEN,KINDERKLIN KASSEL GERMANY UNIV MARBURG KLINIKUM,ZENTRUM KINDERHEILKUNDE MARBURG GERMANY TECH UNIV MUNCHEN WEIHENSTEPHAN,KINDERPOLIKLIN WEIHENSTEPHAN GERMANY EVANG KRANKENHAUS,KINDERKLIN LIPPSTADT LIPPSTADT GERMANY STADT KRANKENHAUS,KINDERKLIN ROSENHEIM GERMANY KINDERKLIN KREISKRANKENHAUS OFFENBURG OFFENBURG GERMANY DIAKONIE KRANKENHAUS,KINDERFACHABT BAD KREUZNACH GERMANY KLINIKUM HOYERSWERDA,KINDERKLIN HOYERSWERDA GERMANY KLINIKUM ASCHAFFENBURG,KINDERKLIN ASCHAFFENBURG GERMANY STADT KRANKENHAUS,KINDERKLIN KEMPERHOF KOBLENZ GERMANY ST ELIZABETH HOSP,KINDERABT NEUWIED NEUWIED GERMANY KREISKRANKENHAUSES,KINDERABT EISENBACH GERMANY ST ANSGAR KRANKENHAUS,FRUHGEBORENEN ABT HOXTER GERMANY STADT KRANKENANSTALTEN DELMENHORST,KINDERKLIN DELMENHORST GERMANY DIAKONIE KRANKENHAUS ROTENBURG,KINDERKLIN ROTENBURG GERMANY
Titolo Testata:
Klinische Padiatrie
fascicolo: 6, volume: 208, anno: 1996,
pagine: 355 - 365
SICI:
0300-8630(1996)208:6<355:TONRS(>2.0.ZU;2-H
Fonte:
ISI
Lingua:
GER
Soggetto:
BIRTH-WEIGHT INFANTS; BLOOD-FLOW VELOCITY; SURFACTANT THERAPY; CONTROLLED TRIAL; SYNTHETIC SURFACTANT; PULMONARY HEMORRHAGE; MORTALITY; SINGLE; GRAMS;
Keywords:
RESPIRATORY DISTRESS SYNDROME; SURFACTANT TREATMENT; OBSERVATIONAL STUDY; SAFETY CONSIDERATIONS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
34
Recensione:
Indirizzi per estratti:
Citazione:
R.R. Wauer et al., "THERAPY OF NEONATAL RESPIRATORY-DISTRESS SYNDROME (NRDS) BY ALVEOFACT(R) - RESULTS OF A PROSPECTIVE OBSERVATIONAL STUDY", Klinische Padiatrie, 208(6), 1996, pp. 355-365

Abstract

Aim After registration of the bovine Surfactant Alveofact(R) (Fa. Thomae) for treatment of neonatal respiratory distress syndrom (RDS) an observational study was performed in 47 german neonatal departments to register indication, effectivity, mode of administration and unexpected side effects. Methods 680 ventilated preterm infants (gestational weeks 29,5+/-2,9; birth weight 1359+/-507 g) were enrolled in an uncontrolled clinical study with study-protocol, prospectively defined outcomes and covariates, manual of operation, central control system, biometrical control. Results Surfactant was applicated at a postnatal age of2 hours 56 minutes (median). Only 2.9% of newborn infants got the first surfactant dosis <6 min postnatally, 19.4% between 6 ... 60 min and77.7% >60 min postnatally. Following 1338 instillations in 76% an improved lung function, in 21% no change and in 3% a worsening was observed. During the study the total dose of surfactant increased. Safety considerations determined by the rate of pulmonary and extrapulmonary complications were similar to data of the literature: pneumothorax 12%, pulmonary interstitial emphysema 11.6%, secondary pneumonia 20.4%, broncho-pulmonary dysplasia 27%, pulmonary hemorrhage 2.1%, peri/intraventricular hemorrhage (degree III/IV) 27.9%, ductus arteriosus sus persistens 24.4%, sepsis/meningitis 12.4%. During the study the mortality reduces from 31% (first period) to 18% (third period) the mean was 20%. In 44 infants (6.5%) a disturbed ventilation (airway obstruction, overdystension of pulmonary areas, atelectasis) after surfactant administration was observed. Conclusion In RDS the surfactant Alveofact is preferably used therapeutically (rescue mode), it is effective but not free of risk. Its administration needs for a clear indication. New unknown side effects of Alveofact were not observed.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/03/20 alle ore 14:18:50