Long-term follow-up of premature infants treated with prophylactic, intratracheal recombinant human CuZn superoxide dismutase.
OBJECTIVE
To examine the long-term effects of treatment with recombinant human CuZn superoxide dismutase (rhSOD) in infants enrolled previously in two placebo-controlled trials.


METHODS
Records for 46 (88%) infants were examined, with 19 infants having received either single or multiple intratracheal (i.t.) doses of placebo, 12 having received a single i.t. dose of rhSOD, and 15 having received multiple i.t. doses of rhSOD. Mean age at follow-up was 28 months corrected age. Records were examined for neurologic dysfunction, developmental delay, and any significant medical disorders.


RESULTS
Four placebo infants (21%) had evidence of neurodevelopmental abnormalities and four infants developed asthma. Four single-dose rhSOD infants (33%) had neurodevelopmental abnormalities and two infants developed asthma. One multiple-dose rhSOD infant had evidence of neurodevelopmental abnormalities and one developed asthma. No other differences were found between the placebo and rhSOD groups.


CONCLUSIONS
Preliminary data suggest that rhSOD is safe and not associated with any long-term adverse effects. Further results will depend on the results of multicenter trials of rhSOD in preterm infants.
Davis
J M
JM
Department of Pediatrics, Winthrop University Hospital, Mineola, NY 11501, USA.
Richter
S E
SE
Biswas
S
S
Rosenfeld
W N
WN
Parton
L
L
Gewolb
I H
IH
Parad
R
R
Carlo
W
W
Couser
R J
RJ
Baumgart
S
S
Atluru
V
V
Salerno
L
L
Kassem
N
N
D000280:Administration, Inhalation; D001997:Bronchopulmonary Dysplasia / Q000209:etiology / Q000517:prevention & control*; D018849:Controlled Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D008297:Male; D010865:Pilot Projects; D011379:Prognosis; D011446:Prospective Studies; D011995:Recombination, Genetic; D012127:Respiratory Distress Syndrome, Newborn / Q000150:complications*; D018570:Risk Assessment; D013482:Superoxide Dismutase / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
D013482:Superoxide Dismutase