NeoMero: 2 year follow up of neonatal meningitis and late onset sepsis
Research type
Research Study
Full title
NEURODEVELOPMENTAL FOLLOW UP AT 24 MONTHS CORRECTED AGE OF INFANTS TREATED FOR NEONATAL MENINGITIS AND LATE ONSET SEPSIS IN THE NEOMERO TRIALS
IRAS ID
159011
Contact name
Paul Heath
Contact email
Sponsor organisation
Fondazione Penta Onlus
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Bacterial infections are an important cause of illness, prolonged hospitalisation and death in babies, particularly in their first three months of life. These infections, especially meningitis, can affect the baby’s developing brain and lead to serious long-term problems such as cerebral palsy and deafness.
The antibiotic meropenem is the focus of the NeoMero studies. They look at how well it works, and how safe it is, in babies under three months of age. NeoMero1 looked at meropenem in sepsis (‘blood poisoning’) and NeoMero2 looked at meropenem in meningitis (an infection of a part of the brain called the meninges). The NeoMero studies took place in a number of different countries in Europe. NeoMero1 was in Estonia, Italy, Greece, Lithuania, Spain, and Turkey. Neomero2 was in these countries and additionally in the United Kingdom and the Netherlands.
We propose, in the UK, to follow-up babies that were part of the NeoMero2 study.
We wish to do this because understanding the consequences of infections in babies is important when trying to develop ways of preventing or reducing the rates of infection. It is also important for planning the services needed for these children (e.g. educational or physiotherapy support) and the cost of these services. It is also important to have this knowledge about long-term outcomes when counselling parents at the time of their baby’s illness.REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0348
Date of REC Opinion
30 Jun 2015
REC opinion
Further Information Favourable Opinion