The DESiGN trial: does the growth assessment protocol (GAP) find which small babies are at risk?

Dr Dharmintra Pasupathy, Professor Jane Sandall, Mr Paul Seed, Dr Annette Briley, Dr Asma Khalil; Dr Matias Vieira; on behalf of the DESiGN consortium

We want to find out if GAP is the best way of telling which small babies are at risk.

Most babies that die before birth seem to have developed normally, but many weigh less than expected. A baby that is smaller than normal for its age is known as small for gestational age, or SGA. A small baby may mean that the placenta hasn’t been working properly, and could be at a higher risk of stillbirth. However, some small babies are completely healthy, and are growing normally.

The question we want to answer is how to tell when a small baby is really at risk, so that we can give it the best chance of a healthy birth. A 2013 study showed that finding out which babies really are too small can halve the risk of stillbirth. Telling when a baby is too small and might be in danger can depend on things like the size and ethnicity of its mother. This means that simply saying that babies below a certain weight are too small doesn’t work. Some babies on the small side may in fact be perfectly healthy. On the other hand, bigger babies may not be growing normally, but are not seen as SGA because they are above a certain weight.

The Growth Assessment Programme (GAP) tries to solve this problem by taking into account factors that might affect a baby’s growth. Recent studies suggest that using GAP is better at finding which babies are at risk, and areas where many carers began using GAP had 22% fewer stillbirths.  

However, we think more studies need to be done in case other factors influenced these results. DESiGN is a randomised control trial that aims to find out whether the GAP programme really is better for finding out which small babies are at risk.

In the last year, 13 hospitals have agreed to take part and we have begun collecting information. GAP will be introduced to different hospitals in turn. This will allow us to compare hospitals that are using GAP with hospitals that carry on with usual care. We will look at if the GAP programme affects how many babies are stillborn, and if it improves a baby’s chances at health. We will also ask women how they felt about their care. At the end of the trial we will know the best way to find which small babies are at risk, and if using GAP helps prevent stillbirths.

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This study takes place in a Tommy's centre and is funded by Tommy's, SANDS and Guy's and St Thomas' Charity

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