Running clinical trials during a pandemic: PEBBLES call for participants

The study

PEBBLES is a clinical trial that is testing a strategy for preventing eczema and food allergy in infants.

We want to find out if using a particular skin cream – called EpiCeram™ – on babies can help reduce the chances of them developing allergies.

Eczema affects 1 in 3 Australian infants. Children with eczema have an increased risk of developing food allergies and asthma.

The research team responsible for designing and managing the trial is based in the Allergy and Lung Health Unit at the Melbourne School of Population Global Health. The current phase of the study started in March 2018.

Learn more about the PEBBLES study

Who's taking part

Melbourne families with newborn babies – up to three weeks of age – where a parent or older sibling has asthma, eczema, hay fever or food allergy are invited to join the PEBBLES study

Since March 2018, more than 160 babies have completed the study. As of June 2020, there are almost 400 active participants. To be able to confirm if this strategy works, we need a further 360 participants.

Adapting to change

Recruitment for clinical studies has always been a challenge, but COVID-19 has made it even harder. Previously, we recruited participants for PEBBLES from maternity hospitals and ran initial assessments there. Follow-up assessments were held at the Murdoch Children’s Research Institute.

Since the pandemic was declared, we can no longer recruit from hospitals or conduct face-to-face assessments.

We have now moved to online recruitment and virtual assessments, except for our final 12-month assessment. This involves some changes to the study, and the data we collect. In mid-April, we received approval from the Royal Children’s Hospital Human Research Ethics Committee for these changes.

What the study involves

We welcome expressions of interest from pregnant women. Participation in the study starts in the first three weeks after your baby is born and runs for 12 months. We hold an initial assessment with you and your baby by phone, email or video. At the assessment we randomise your baby to the cream or no cream group. All families complete an online weekly diary during the study to document what they are applying to their baby’s skin.

This is followed by an assessment when your baby is six-weeks of age, by, email or video where we look for any early signs of eczema.

The 12-month check-in includes a skin assessment, skin prick test and optional sample collection and collects endpoint data. This assessment is essential as the primary outcomes of the study are measured at this visit. It has continued in-person throughout the pandemic. Parents who are hesitant to attend in-person assessments can postpone these until the State government further eases COVID-19 restrictions.

Join the research

We want to hear from families and expectant parents who are interested in taking part in the PEBBLES study. To learn more, email the team at pebbles-study@unimelb.edu.au or visit PEBBLES Study.

Researchers interested in collaborating, or extending the trial to their institution can email the team at pebbles-study@unimelb.edu.au

You can also share information about PEBBLES on social media, or with people who might be interested in joining the study or collaborating on research.