BALLOON
Research type
Research Study
Full title
A randomised, double-blind, parallel group, placebo controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants
IRAS ID
1007696
Contact name
Sailesh Kotecha
Contact email
Sponsor organisation
Cardiff University
ISRCTN Number
ISRCTN14019493
Research summary
Babies born early or prematurely have under-developed lungs. Many need help with their breathing after birth and some go on to have lifelong lung problems. Premature babies will get infections after discharge which they generally deal with well. The problem is over half get chest infections which further damage the lungs. There are very few treatments available to prevent viral chest infections except against the virus called RSV (Respiratory Syncytial Virus). We want to use a new approach to prepare the babies’ immune system to fight chest infections. Bactek (MV-130) is an oral spray containing harmless dead bacteria, so it works like a vaccine. The dead bacteria should help the baby build a strong immune system, preventing further damage to the lungs by helping fight chest infections. Studies show Bactek decreases chest infections and wheezing safely in children and babies. Only some premature babies have been studied so far, so a larger study is needed to show if Bactek works in premature babies born at less than 30 weeks’ of gestation.
We want to collect data to show if Bactek spray decreases number of visits to the GP, A&E or hospital admissions for chest infections in premature babies when compared to babies who get a placebo (dummy) spray. We will do a study called a blinded, randomised, placebo-controlled trial. After consent from parents, we will allocate babies to one of two treatments. One group will get Bactek and the other a placebo (treatment spray that looks the same but does not contain dead bacteria). Parents and researchers will not know which group the baby is in. The treatment will be given daily from when the baby reaches 37 weeks’ corrected gestation (close to their “due date”) until they are one year from their expected due date.
We wish to include 542 babies to show if chest infections decrease from 55% (the current rate) to 40%. If this treatment works, there will be large savings and it will benefit the parents and babies.REC name
Wales REC 3
REC reference
24/WA/0181
Date of REC Opinion
29 Jul 2024
REC opinion
Further Information Favourable Opinion