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  • 1
    Electronic Resource
    Electronic Resource
    A European multicenter randomized controlled trial of single dose surfactant therapy for idiopathic respiratory distress syndrome (1990)
    Springer
    European journal of pediatrics 149 (1990), S. 416-423 
    Details
    ISSN: 1432-1076
    Keywords: Surfactant ; Idiopathic respiratory distress syndrome ; Clinical trial ; Randomization
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We performed a multicenter prospective randomized controlled trial to determine the efficacy and safety of the surfactant preparation, Survanta (Abbott Laboratories, Chicago, USA), for 750–1750 g infants with idiopathic respiratory distress syndrome, (IRDS) receiving assisted ventilation with 40% or more oxygen. One hundred and six eligible infants from the eight participating centers were randomly assigned between March 1986 and June 1987 to receive either surfactant (100 mg phospholipid/kg, 4 ml/kg) or air (4 ml/kg) administered into the trachea within 8 h of brith (median time of treatment 6.2 h, range 3.2–9.1 h). The study was stopped before enrollment was completed at the request of the United States Food and Drug Administration when significant differences were observed in incidence of periventricular-intraventricular hemorrhage (PIH), between the surfactant treated and control infants. Surfactant treated infants had larger average increases in the arterial-alveolar oxygen ratio, (a/A ratio) (P〈0.0001), and larger average decreases in FiO2 (P〈0.0001) and mean airway pressure, (MAP) (P〈0.017) than controls over the 48 h following treatment. The magnitude of the differences between the surfactant and control groups were 0.19 (SE=0.03) for a/A ratio, −0.28 (SE=0.04) for FiO2 and −1.7 cm H2O (SE=0.70) for MAP. The clinical status on days 7 and 28 after treatment was classified using four predefined ordered categories: (1) no respiratory support; (2) supplemental O2 with or without continuous positive airway pressure (CPAP); (3) intermittent mandatory ventilation; and (4) death. There were no statistically significant differences in the status categories on days 7 or 28 between surfactant and control infants. There were no significant differences between the groups with respect to the incidence of patent ductus arteriosus, bronchopulmonary dysplasia, necrotizing entero-colitis, air leaks or death. There was a statistically significant difference between treated and control infants in the frequency and severity of periventricular-intraventricular hemorrhage (PIH) (Cochran-Mantel-Haenszelχ 2adj=6.36,P=0.01). Hemorrhages occurred in 59.6% of surfactant treated infants and 26.9% of controls. Severe hemorrhages (grades 3 or 4) occurred in 38.5% of surfactant treated infants and 15.4% of controls (χ 2adj=4.01,P=0.045). We conclude that the intratracheal administration of Survanta prior to 8 h of age to infants with IRDS receiving assisted ventilation with 40% or more oxygen results in a reduction in the severity of respiratory distress during the 48 h after therapy. Because of the difference in incidence of PIH between surfactant and control infants in this study, we recommend that future clinical trials of surfactant include more frequent prospective serial ultrasound evaluations for diagnosis of hemorrhage.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02009663
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  • 2
    Electronic Resource
    Electronic Resource
    Postpartale Risikofaktoren in den Entwicklung von Kindern opiatabhängiger Mütter Ein Vergleich zwischen Müttern mit und ohne Methadon-Substitution (2000)
    Springer
    Der Nervenarzt 71 (2000), S. 730-736 
    Details
    ISSN: 1433-0407
    Keywords: Schlüsselwörter Neonatales Abstinenzsyndrom ; Methadon ; Heroin ; Sucht ; Kinder drogenabhängiger Mütter ; Keywords Neonatal abstinence syndrome ; Methadone ; Heroin ; Addiction ; Children of drug-dependent mothers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Abstract In a retrospective case control study at the University of Frankfurt, Germany, 101 babies born to opiate-addicted mothers were identified from birth charts from 1988 to 1995. After birth, they developed a withdrawal syndrome (neonatal abstinence syndrome). Fifty control infants and their mothers were selected from neonatal wards. The group of opiate-exposed babies was subdivided into a group born to mothers without methadone treatment (n=48) and a group born to mothers who were enrolled in a methadone program (n=51). The methadone infants had a significantly higher mean birth weight (2822 g) than children in the group without methadone (2471 g). The abstinence syndrome was much more intense in the methadone group (convulsions 47.1%) than in heroin-exposed babies without methadone treatment (convulsions 27.1%). Women in methadone maintenance programs lived in more stable socioeconomic conditions than opiate-addicted women without methadone substitution. Moreover, they cared significantly better for their babies: 81.3% of the methadone mothers visited their children on a regular basis and 90.9% cared adequately. The data emphasize the need in future research to look more closely at the role of methadone treatment programs in the development of opiate-exposed babies.
    Notes: Zusammenfassung In einer retrospektiven Fall-Kontroll-Studie (Geburtsjahrgänge 1988–1995) an der Universitätsklinik Frankfurt a. M. wurden in der Neonatologie 101 Neugeborene von opiatabhängigen Müttern identifiziert. Postpartal zeigten die Kinder ein Entzugssyndrom (neonatales Abstinenzsyndrom). Eine Kontrollgruppe bestand aus 50 drogenfreien Müttern und ihren Neugeborenen. Die opiatexponierten Kinder wurden dichotomisiert in eine Gruppe von Kindern, deren Mütter Methadon-substituiert wurden (n=51), und in eine Gruppe ohne Methadon-Substitution n=48): Methadon-Kinder hatten ein höheres durchschnittliches Geburtsgewicht (2822 g) als Kinder von nicht substituierten Müttern (2471 g). Das Abstinenzsyndrom verlief in der Methadon-Gruppe schwerer (Krampfanfälle in 47,1%) als in der Gruppe ohne Substitution (Krampfanfälle in 27,1%). Die substituierten Frauen lebten in stabileren sozioökonomischen Verhältnissen als nicht substituierte Frauen und sie kümmerten sich signifikant besser um ihre Kinder: 81,3% der substituierten Mütter besuchten ihre Kinder regelmäßig, das Zuwendungsverhalten war bei 90,9% angemessen. Diese Datenlage gibt Anlass dazu, die Rolle der Methadon-Substitution in der Entwicklung von Kindern opiatabhängiger Mütter zukünftig in der Forschung verstärkt zu berücksichtigen.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s001150050657
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    Paper (German National Licenses)
    Fulltext
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