Revisiting landmark steroids trial yields new data

Contemporary research techniques have yielded new findings from a landmark healthcare trial carried out 50 years ago that changed clinical practice globally.

Obstetrician Professor Graham ‘Mont’ Liggins and paediatrician colleague Dr Ross Howie produced their first report from the Auckland Steroid Trial at National Women’s Hospital in the journal Pediatrics in 1972.

The pair found that two corticosteroid injections given to pregnant women at risk of preterm birth halved incidence of respiratory distress in the babies and significantly reduced neonatal deaths.

Now a team from the Liggins Institute at the University of Auckland, named in recognition of the importance of this trial, has revisited the records, handwritten in notebooks, from that original trial, something they had to do anyway as part of a 50-year follow-up study.

“We went back to the original data and it became obvious, something we knew, but it became clearer, that a lot of the data had never been published,” says principle investigator Distinguished Professor Dame Jane Harding.

“It’s such a landmark trial, which is still highly cited, so we thought it would be worth putting together and analysing the current way, so readers have the full trial information.”

At the time, Liggins and Howie published findings from the first more than 200 trial participants, but they continued the trial for several years after that and at a later stage tried doubling the dose.

“So one of our new findings is that doubling the dose actually didn’t help, which was there in the trial, but has never been published,” Harding says.

Contemporary statistical methods have yielded findings that weren’t possible then, for example, allowing results from boys and girls to be separated. The steroids benefitted boy babies more than girls.

A Cochrane meta-analysis of a large number of steroid trials supported the original study’s key findings, including a reduction in mortality. However, many new questions have arisen.

Other significant findings in the new analysis of the original trial relate to questions currently being researched, chiefly that there was no significant impact of steroids on breastfeeding at the time of hospital discharge or on low blood sugar levels in the babies.

Meanwhile, work continues on the 50-year follow-up study, with results due to be completed in 2023.

• Read: Betamethasone for preterm birth: Auckland Steroid Trial full results and new insights 50 years on.