Recommendations for research

Guidance

1 Symptoms of gastro-oesophageal reflux disease (GORD) in infants, children and young people with a neurodisability
2 Cows' milk protein elimination in formula-fed infants
3 Fundoplication and oesophageal pH monitoring

Recommendations for research

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

1 Symptoms of gastro-oesophageal reflux disease (GORD) in infants, children and young people with a neurodisability

What are the symptoms of GORD in infants, children and young people with a neurodisability?

Why this is important

The evidence reviewed on the symptoms associated with GORD in children and young people with a neurodisability was limited to 3 studies and graded as low‑ to very low‑quality. The lack of a set of clearly defined features makes GORD difficult to recognise and differentiate from other vomiting problems. The proposed study would use objective measures of reflux (such as oesophageal pH monitoring) to assess GORD symptoms in infants, children and young people with a neurodisability.

2 Cows' milk protein elimination in formula-fed infants

What is the effectiveness and cost effectiveness of a trial of hydrolysed formula in formula‑fed infants with frequent regurgitation associated with marked distress?

Why this is important

There is a widespread belief that GOR and/or GORD in formula‑fed infants is often caused by intolerance to cows' milk. As a result, health professionals often prescribe a trial of hydrolysed formula as a substitute for cows' milk formula. This has resource implications because hydrolysed formula is more expensive than cows' milk formula. Additionally, there is no evidence on the clinical or cost effectiveness of this approach. Therefore, it is proposed that a randomised controlled trial is undertaken to explore this question. It is important to consider 2 population subgroups:

infants with a personal or family history of atopic conditions
infants whose GOR and/or GORD has not responded to the initial management outlined in this guideline (up to and including alginates).

3 Fundoplication and oesophageal pH monitoring

In infants, children and young people with overt or occult reflux, is fundoplication effective in reducing acid reflux as determined by oesophageal pH monitoring?

Why this is important

Fundoplication is used to manage severe GORD. At present, there is limited evidence that overt regurgitation is reduced after surgery. However, this has not been objectively measured. In addition, the effect of surgery on occult reflux has not been assessed. This is important because surgery may be masking a continuing problem. The proposed study would monitor regurgitation before and after fundoplication using oesophageal pH monitoring. This may help health professionals identify which infants, children and young people will benefit from surgery.