BALLOON

A randomised, double-blind, parallel group, placebo controlled, trial of bactek for the prevention of lower respiratory tract infections in preterm infants.

Background

Babies born early or prematurely have under-developed lungs. Many will need help with their breathing after birth, sometimes for several weeks. Some babies will go on to have lifelong lung problems.

Like all babies, premature babies will get infections which they generally deal with well. The main problem is that over half will get chest infections (“pneumonia”, commonly due to viruses) which will further damage the lungs.

There are very few treatments available to prevent viral chest infections except against the virus called RSV (Respiratory Syncytial Virus).

Helping babies’ immune system to fight chest infections

We want to use a new approach to prepare the babies’ immune system to fight chest infections. Bactek (MV130) is an under the tongue 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 to fight chest infections. Studies show that Bactek decreases chest infections and wheezing safely in children and babies. Because only some premature babies have been studied so far, a larger study is needed to show if Bactek works in premature babies born at ≤29+6 weeks of gestation.

Study aims

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” or RCT. This means with consent from parents, we will use a computer to allocate their baby to one of two treatments.

One group will get Bactek and the other will get a placebo (“dummy” treatment spray that looks the same as Bactek but does not contain any dead bacteria). The parents and the researchers will not know which group the baby is in.

The allocated treatment will be given daily from when the baby reaches 37 weeks’ corrected gestation (close to their “due date”) or discharge if earlier until they are one year from their expected due date.

Sample size

We wish to include 542 babies to show if chest infections decrease in an important way – which we feel is to decrease the current rate of chest infection from 55% (55 babies in very 100) to 40% (40 babies in every 100). We have allowed for one in seven babies not being able to complete the study.

Potential benefits of the study

If this treatment works, there will be large savings. The cost to the health service for each hospital admission for a chest infection is over £6,000 (in 2012). More importantly, it will benefit the parents and their babies.