Retrospective search for bleeding diathesis among premature newborn infants with pulmonary hemorrhage after synthetic surfactant treatment. The American Exosurf Neonatal Study Group I, and the Canadian Exosurf Neonatal Study Group.
In an across study analysis of five multicenter, placebo-controlled trials of the synthetic surfactant, Exosurf Neonatal, involving infants with birth weights 700 gm or greater the incidence of clinical pulmonary hemorrhage was 1.9% in treated infants and 1.0% in control infants. To determine whether this apparent increase in pulmonary hemorrhage was the result of a bleeding diathesis, we retrospectively reviewed charts for 39 of 41 infants with clinical pulmonary hemorrhage. The incidence of nonpulmonary bleeding was the same in control- and surfactant-treated infants. Platelet counts, hematocrit values, and the number of transfusions with platelets or red blood cells did not differ between the two groups. There was no evidence that surfactant treatment was specifically associated with a generalized bleeding diathesis.
Long
W
W
Department of Pediatrics, University of North Carolina, Chapel Hill.
Corbet
A
A
Allen
A
A
McMillan
D
D
Boros
S
S
Vaughan
R
R
Gerdes
J
J
Houle
L
L
Edwards
K
K
Schiff
D
D
D004311:Double-Blind Method; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000009:adverse effects* / Q000627:therapeutic use; D006474:Hemorrhagic Disorders / Q000139:chemically induced*; D006801:Humans; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000139:chemically induced*; D008171:Lung Diseases / Q000139:chemically induced*; D010767:Phosphorylcholine; D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use; D011663:Pulmonary Surfactants / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies
D004338:Drug Combinations; D005233:Fatty Alcohols; D011663:Pulmonary Surfactants; D010767:Phosphorylcholine; D011092:Polyethylene Glycols; C047049:dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination