Related Experiment Videos
Health and developmental outcomes of a surfactant controlled trial: follow-up at 2 years
J Ware1, H W Taeusch, R F Soll
1Department of Medicine, Harvard Medical School, Boston, Massachusetts.
Insights
Surfactant therapy for premature infants with respiratory distress syndrome shows no major long-term side effects. Health and developmental assessments at 1 and 2 years revealed comparable outcomes between treated and control groups.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Clinical Trials
Background:
- Surfactant therapy is established to improve respiratory distress syndrome (RDS) in infants.
- Long-term consequences of surfactant treatment remain less understood.
- Bovine surfactant is a common therapeutic agent for RDS.
Purpose of the Study:
- To assess the long-term health and developmental outcomes of infants treated with bovine surfactant.
- To evaluate potential side effects at 1 and 2 years of age.
Main Methods:
- Follow-up assessment of 32 survivors from a randomized clinical trial of bovine surfactant therapy.
- Health and developmental assessments including Bayley Scales of Infant Development at 1 and 2 years.
- Comparison of outcomes between surfactant-treated and control groups.
Main Results:
- No significant differences in overall abnormal findings between groups.
- A trend towards more allergic manifestations in the control group (38% vs 7%).
- Comparable mental and motor scores on the Bayley Scales at 1 and 2 years.
Conclusions:
- Bovine surfactant therapy appears safe with no major long-term adverse effects.
- Follow-up studies support the safety profile of surfactant treatment in infants.
- Further research may explore the trend in allergic manifestations.
Abstract:
Several randomized clinical trials have shown that surfactant therapy improves the pulmonary status of infants with respiratory distress syndrome and has the potential to reduce morbidity and mortality in these infants. Relatively little is known, however, about the long-term consequences of surfactant treatment. In this report, the results of health and developmental assessment are described at 1 and 2 years of age of 32 survivors of an initial group of 41 infants enrolled in a randomized clinical trial of bovine surfactant therapy. The frequencies of abnormal findings were comparable in the two groups although there was a trend toward a greater frequency of allergic manifestations in the control group (6 of 16 (38%) vs 1 of 15 (7%), P = .08). Similarly, no differences were seen in the mental and motor scores of the Bayley Scales of Infant Development at either 1 or 2 years of age. This study and other recently published reports of follow-up studies of infants treated with surfactant provide encouraging evidence that major long-term side effects do not result from surfactant therapy.