CHAPEL HILL, NC - A study published in the New England Journal of Medicine concludes that hydrocortisone is no more effective than placebo at preventing damage that can result from oxygen and ventilator therapy necessary to keep preterm infants alive. The study was conducted through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network and was led by a research team at the University of New Mexico Health Sciences Center in Albuquerque. Institutions across the country were involved in the trial, including a team at UNC led by Matthew Laughon, MD, MPH, professor of pediatrics at the UNC School of Medicine.
The clinical trial studied the use of hydrocortisone as a potential treatment for the condition known as bronchopulmonary dysplasia (BPD), a serious condition that can develop in newborns as a complication of another breathing condition or from lung injuries caused by treatments like mechanical ventilation.
"Bronchopulmonary dysplasia is the most common lung problem in premature infants," said Laughon. Premature infants with bronchopulmonary dysplasia have longer hospitalizations and more problems when they go home compared to infants without bronchopulmonary dysplasia. Neonatology has been trying for decades to find a drug to reduce the frequency of this problem."
The trial enrolled 800 infants born before the 30th week of pregnancy who had been on a ventilator for at least seven days. From 14 days to 28 days, in addition to receiving standard care and ventilator therapy, infants were randomly assigned to receive either hydrocortisone or a placebo. Of the hydrocortisone-treated infants, 16.6% survived to 36 weeks without moderate or severe bronchopulmonary dysplasia, which did not differ significantly from 13.2% in the placebo group. The rate of neurodevelopmental impairment did not differ significantly between the groups (36.9% vs. 37.3%). The hydrocortisone group was more likely to need drug treatment for hypertension than the placebo group (4.3% vs. 1.0%).
"Before this study, neonatologists were increasingly using hydrocortisone off-label for preventing bronchopulmonary dysplasia. This study, although there was no difference in lung disease, was reassuring that there was no neurodevelopmental problems identified at two years of age. This is important information for neonatologists to know about these critically ill infants. The next steps will be to continue to follow these children into school age," said Laughon.
In conjunction with this study an editorial was published in the New England Journal of Medicine that states that glucocorticoids should not be given to prevent BPD, and research should instead focus on their potential role in the amelioration of severe respiratory disease.
This research was funded by the National Institutes of Health.
