Bradford hospital staff are celebrating the recruitment of not just the 100th but the 101st baby to a neonatal clinical research trial which could have a major impact on infant health.
The ELFIN study is a multi-centre, randomised, placebo-controlled trial which involves giving lactoferrin (a natural infection-reducing cow’s milk protein) to very preterm infants to evaluate if it can reduce infection.
The latest ‘recruits’ at the neonatal unit at Bradford Royal Infirmary, part of Bradford Teaching Hospitals NHS Foundation Trust are twin girls – Ayat and Hiba – who were born at just 25 weeks’ and six days’ gestation, to mum, Sara Wadood.
About 20 per cent of very preterm babies born before 32 weeks’ gestation acquire serious infections and so better methods of infection prevention are needed. The ELFIN babies have to be born before 32 weeks’ gestation and remain on the trial until they reach 34 weeks.
Lead Research Nurse, Kelly Young said: “We are really pleased to be taking part in the ELFIN trial because the Trust is passionate about research and the importance of it. We know what a difference research can make, and it’s important we offer our parents the opportunity for their babies to be involved in these trials.
“This is a trial which has the potential to make a real difference to the long-term outcomes of babies’ health because it could prevent the late onset of infections which can impact negatively on preterm babies and in some cases be life-threatening.
“Lactoferrin is a naturally-occurring protein in breast milk and introducing this milk protein may reduce the risk of these infections by as much as 50 per cent.”
Kelly added that the trial, which is sponsored by the University of Oxford, involves more than 20 centres across the UK which collectively have recruited 538 babies up to date – making Bradford’s contribution so far nearly 20 per cent. The national recruitment target is 2,200 babies.
Consultant Neonatologist, Sam Oddie, who is Principal Investigator at BRI, has been involved in the design and running of the trial.
He said: “From the beginning we have been right behind this trial - we recruited the first patient - and are very pleased to have recruited so many babies to ELFIN. We have found that parents are very happy to join in studies if we take the time to explain them carefully; indeed many families are very content to join more than one study.
“The results are a bit of a way off yet but we are really hopeful that ELFIN will be an important part of the answer as to whether all very early babies should be given supplementary lactoferrin.”
The protein, which is in powder form and mixed with mum’s breast milk and water to make a 1.5ml dose, is given once a day. The trial is completely blind and neither staff nor parents know whether babies are allocated to lactoferrin or the placebo.
The trial closes in December 2017, and the results, which will be evaluated by the National Perinatal Epidemiology Unit, are expected in late 2018.
Proud dad of the twins, who were born on 15 May, Sajid Hussain said: “It is so important that we take part in these trials because the outcomes really can help other babies in the future.”
Mum, Sara added: “We are so grateful that our babies are in such a wonderful facility as the Bradford neonatal unit and are being given the chance to be involved in this ground-breaking research.”
The babies are also taking part in the Prevail trial which compares standard intravenous feeding lines with those impregnated with antibiotics.
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