Anti-reflux medication safety among preterm infants
Research type
Research Study
Full title
An observational study of the association between anti-reflux medication use and adverse outcomes in preterm infants
IRAS ID
289926
Contact name
Shalini Ojha
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
000, NA
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Gastroesophageal reflux (GER), defined as the passage of stomach contents into the food pipe. It can be a normal occurrence in babies born early (i.e. preterm). However, some babies can have difficulties in breathing or feeding which is often thought to be related to GER. Anti-reflux medicines (ARM) are frequently used to treat GER although most are not licensed for use in babies. In addition, studies show that treating GER does not improve breathing and feeding problems in preterm babies. Despite this nearly a third of preterm babies, receive anti-reflux medications while in neonatal units and are often discharged home on them.
Recently, concerns were raised regarding the safety of these drugs, especially among preterm infants. Stomach acid is a defence against invading germs that enter the body with food. Suppressing acid in the stomach can lead to reduced defence against harmful germs. The changed stomach environment also changes the beneficial growth of friendly bacteria in the gut which are instead replaced by harmful germs.
In preterm infants, studies show that the use of anti-reflux medications may be linked to increased risk of infections, life-threatening gut condition called necrotising enterocolitis (NEC), and even death.
In this study, we will take routinely collected de-identified data from National Neonatal Research Database which collects data from all neonatal units in England and Wales. We will look at preterm babies who had anti-reflux medications and compare the risk of infections, NEC, death and other poor outcomes in them with those in babies who did not receive anti-reflux medications. The findings from this study will help us determine the safety of using anti-reflux medications in preterm babies and rationalise the use of these medicines. The results will also inform guidelines for management of GERD and future studies in this area.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0055
Date of REC Opinion
3 Mar 2021
REC opinion
Favourable Opinion