JAMA study: caffeine treatment doesn’t cut hospital stays for moderately preterm infants

RTI-coordinated clinical trial across 29 hospitals finds no discharge benefit from extended caffeine use  

RESEARCH TRIANGLE PARK, N.C. — A new study conducted by the NICHD Neonatal Research Network (NRN) and led by University of Alabama at Birmingham in collaboration with independent scientific research institute RTI International, and other partners, has found that extending caffeine treatment in moderately preterm infants does not reduce their hospitalization duration. The findings have been published in the Journal of the American Medical Association (JAMA).  

RTI served as the Data Coordinating Center (DCC) for the randomized clinical trial, with Abhik Das, Ph.D., Distinguished Fellow, serving as principal investigator and Benjamin Carper as senior statistician. The trial was conducted across 29 hospitals in the U.S. that are part of the NRN.  

“This study gave us a clearer picture of what extended caffeine use really does—and doesn’t do—for moderately preterm babies,” said Das. “It helped researchers settle an important question: giving caffeine longer helps babies stop having apnea sooner, but it doesn’t get them out of the hospital faster. That’s critical information for doctors and families who are making care decisions.” 

The trial enrolled 827 infants who were on caffeine treatment at 33 to 35 weeks postmenstrual age and receiving full feeds. Infants were randomized to receive either oral caffeine citrate or a placebo until 28 days post-discharge. 

The results showed no difference in the number of days of hospitalization between the caffeine and placebo groups, with a median of 18.0 days for the caffeine group and 16.5 days for the placebo group. The research team found no difference in the time it took for infants in both groups to reach full physical maturity. However, infants who received caffeine stopped having apnea sooner, taking approximately six days compared to 10 days for those who received the placebo. 

“Extended caffeine is a common practice in these babies, but it is not supported by comprehensive research,” said Waldemar A. Carlo, M.D., professor of pediatrics at the University of Alabama at Birmingham and principal investigator for this study. “This large, multicenter trial shows that while caffeine helps with breathing, it’s not the only piece of the puzzle and readiness for oral feeding is just as important for a baby to be discharged from the hospital. These findings suggest that physicians could modify the present practice by not prescribing extended caffeine or give it selectively to preterm infants on full oral feedings who are still experiencing apnea.” 

The study also found no significant differences in rates of readmissions, sick visits or adverse events between the two groups. The trial's findings are consistent with previous studies that have shown caffeine treatment to be effective in reducing apnea but not necessarily in shortening hospital stays. 

View the full study 

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