[img_inline align=”right” src=”http://padnws01.mcmaster.ca/images/schmidt.jpg” caption=”(L to R) Barbara Schmidt (principle investigator), Carole Chambers, Robin Roberts, Judy D’ilario, Lorrie Costantini “]A study on the use of caffeine to help regulate the breathing of very preterm babies has produced some early positive results.

Infants treated with caffeine therapy for apnea needed less artificial assistance with breathing and had a lower incidence of abnormal lung development than infants who were given a placebo, according to an article which appears in the May 18 issue of the New England Journal of Medicine (NEJM).

Caffeine and similar drugs have been used for more than 25 years to make the breathing of very preterm babies more regular.

The international study involves more than 2,000 infants who weighed between 500 and 1250 grams at birth, and who were at risk of apnea – interrupted or irregular breathing due to immaturity. The ongoing study, which is being led by researchers at McMaster University, will continue to follow the children until they reach the age of five.

Barbara Schmidt, a professor of pediatrics and clinical epidemiology & biostatistics at McMaster University and the principal investigator of the research project, said that the interim results of the study showed that 47 per cent of the infants receiving the placebo still needed to be given extra oxygen at a post conceptual age of 36 weeks. Among the babies receiving caffeine therapy, only 36 per cent needed extra oxygen by the time they reached the same age.

The control group receiving the placebo also needed an extra week of ventilator therapy to support their irregular breathing, as compared to the babies receiving caffeine, said Schmidt, a neonatologist at the McMaster Children's Hospital.

Although infants in the caffeine group gained less weight in the first three weeks after starting the therapy, the study detected no other benefits or harm from caffeine among the babies during their stays in neonatal intensive care units.

However, Schmidt emphasized that these results are preliminary. “This is not the final word about this therapy,” she said.

The research project intends to address long-standing concerns about possible long-term adverse effects of caffeine therapy used in pre-term infants, explained Schmidt.

Apnea occurs in about 85 per cent of infants who are born at less than 34 weeks gestation. For more than 25 years, therapies known as methylxanthines, including caffeine, have been used to reduce the frequency of apnea and the need for mechanical ventilation. However, it has remained uncertain whether the use of methylxanthines has any additional short or long-term benefits or risks in premature infants.

The Caffeine for Apnea of Prematurity (CAP) project enrolled 2006 premature infants who were born between October 1999 and October 2004 in nine countries. The main goal of the study is to determine if the use of caffeine has any effect on rates of death, cerebral palsy, cognitive delay, deafness or blindness at the end of the second year of life. All children will also be re-assessed at 5 years to obtain more precise information on their development as they approach school age.

The interim results included in the NEJM article were gathered until the babies were discharged from hospital for the first time. The article concludes that since abnormal lung development is an important risk factor for neurosensory impairment in early childhood, the study's interim results suggest potential for long-term benefits of caffeine therapy in infants with very low birth weights.

“However, information on short-term outcomes is insufficient to assess the overall efficacy and risk of neonatal interventions,” Schmidt said. “Follow-up of our study currently in progress is needed before one can confidently recommend the standard use of methylxanthine therapy for apnea of prematurity.”

The next stage of follow-up is expected to be completed by the end of this year, when all babies in the study have reached the age of 18 to 21 months.

The project is being funded by the Canadian Institutes of Health Research and the National Health and Medical Research Council of Australia.