Major study to look at treatment for reflux in babies
Research co-led by a Birmingham Children’s Hospital professor will analyse whether medication for reflux helps to relieve symptoms in babies, thanks to a £2.6 million grant.
The study will review the benefits and side effects of Omeprazole, which is used to treat babies with gastro-oesophageal reflux.
Called Omeprazole for Treatment of Term and preterm infants with gastro-oEsophageal Reflux (OTTER), the study was awarded the grant from the National Institute for Health and Care Research (NIHR).
It will be led by Professor Deepthi Jyothish, Consultant in General Paediatrics at Birmingham Women’s and Children’s NHS Foundation Trust, together with Professor Mark Johnson in Southampton.
Prof Jyothish said: “Omeprazole is already commonly prescribed for babies with reflux, despite the lack of evidence around the benefits and side effects when used.
“This research will provide the evidence to support decisions around whether to prescribe it for babies and in turn help improve clinical care and outcomes for babies and their families."
Babies whose parents agree for them to take part will be given either omeprazole or placebo for four weeks and their reflux symptoms assessed and compared between the two groups.
Neither parents nor doctors treating the babies will know which treatment the babies received.
The OTTER study will track any potential side effects for six months from recruitment to identify any safety concerns with omeprazole treatment. The study will also evaluate parental experiences of reflux, its treatment and the impact on their lives.
The three-year research programme will be recruiting babies from GP practices as well as hospitals across the UK.
Professor Jyothish is also an Honorary Professor at the College of Medicine and Health, at the University of Birmingham, whilst Professor Johnson is an Honorary Consultant Neonatologist at Southampton Children’s Hospital and Professor of Child Health at the University of Southampton.
Funded by the NIHR Health Technology Assessment Programme, the OTTER study is expected to start recruiting this summer.