A common medicine used to treat babies with reflux is to be assessed in a new trial.
The National Institute for Health and Care Research (NIHR) have awarded £2.5 million to carry out the national study.
It will be led by Southampton’s Professor Mark Johnson, together with Dr Deepthi Jyothish in Birmingham. It will be delivered within the NIHR Southampton Biomedical Research Centre.
Babies under six months of age will be recruited from 10 health centres and 35 hospitals across the UK.
The three-year programme aims to inform guidance on future treatment.
Treating babies with reflux
Babies with reflux can bring up milk, be sick or become very uncomfortable during or shortly after feeding.
It’s very common and most babies have only mild symptoms and do not need any treatment. It usually gets better on its own over the first few months.
However, in some babies, symptoms can be more severe with pain, discomfort, screaming and poor weight gain.
Reflux is especially common in premature babies.
An initial treatment for formula-fed babies is to use special powder to thicken their usual formula milk. Alternatively, parents can switch to using pre-thickened formula milk. In breast-fed babies products can be given that thicken in the stomach to help prevent milk from coming back up.
These methods are not always effective and can be challenging to use in breast fed babies. In cases where babies’ symptoms do not improve, or where thickener products can’t be used, the doctor may prescribe a medicine to stop their stomach producing as much acid.
The most prescribed of these medicines for young babies is omeprazole.
Although omeprazole has been used for a while, and is helpful in adults who have heartburn and indigestion, it is not clear if it is effective in babies. This is because the symptoms experienced by babies with reflux can be due to milk coming back up into the mouth in addition to the discomfort caused by stomach acid.
Stomach acid may also be important for babies to help protect them from infections or absorb some nutrients, so reducing it may cause problems.
Investigating omeprazole
The OTTER trial will review the effectiveness of omeprazole as a treatment for babies with reflux.
Babies taking part in the trial will be less than six months of age and have been diagnosed with gastro-oesophageal reflux. A group of babies born prematurely will be included, together with a group of babies born around their due date.
Babies will be given either omeprazole or placebo (a fake treatment with no medicinal effect) for four weeks. Neither parents nor doctors treating the babies will know which treatment they received.
Their reflux symptoms will be monitored and the omeprazole and placebo groups compared. This will help determine if omeprazole is an effective treatment.
The researchers will also track any potential side effects for six months after a baby joins. They will compare these against the placebo group to identify any safety concerns with omeprazole treatment. The study will also ask parents about their experiences of reflux and its treatment,
and the impact on their lives.
Helping babies grow
Prof Johnson is Professor of Child Health at the University of Southampton, and an honorary consultant neonatologist at Southampton Children’s Hospital. He is part of the University Hospital Southampton Research Leaders Programme.
Co-chief investigator Dr Jyothish is a consultant paediatrician in Birmingham Women's and Children's Hospital NHS Trust.
Prof Johnson said: “Omeprazole is already commonly prescribed for babies with reflux. This research will provide the evidence doctors need to support decisions around whether to prescribe it for young babies. This is particularly important for premature babies, who are more likely to have reflux.
“Knowing which medicines work will mean doctors can treat babies with this condition more effectively and safely, relieving their symptoms and helping them to feed and grow. This in turn would have a positive impact in them and their families.”
The OTTER trial is expected to start in spring 2025 and will last for over three years.
It has been funded by the NIHR Health Technology Assessment Programme.
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