UK Premature Baby Ventilation Trial Cleared Of Causing Long-term Harm To Participants

Main Category: Clinical Trials / Drug Trials
Article Date: 03 Apr 2006 - 9:00 PDT

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Premature babies with breathing problems who were given continuous negative-extrathoracic-pressure (CNEP) ventilation in a UK trial do not have poorer long-term outcomes when compared with those who received standard treatment, concludes a study in this week's issue of The Lancet.

CNEP is a treatment where pressure is applied to a child's chest to assist breathing. In the early 1990s, David Southall and colleagues did a randomised controlled trial comparing CNEP with standard ventilation support (breathing tube inserted through the larynx) for premature babies with respiratory distress syndrome*. After the study's publication there was concern among some parents of children on the trial that CNEP might lead to death or disability, following analysis which showed a small excess of deaths and infants with abnormal brain scans in the CNEP group.

Neil Marlow (Queen's Medical Centre, Nottingham) and colleagues, who had no role in the original trial, were commissioned to study the long-term consequences of the CNEP trial. The team were able to follow-up 133 of the 205 survivors from the original study, now aged between 9-15 years. They found that there was no evidence of poorer long-term outcome in the CNEP group. In fact, the team found that language and visual/spatial skills were substantially higher in the CNEP group than in the standard treatment group.

Professor Marlow states: "In the original study report, there were advantages to children who received CNEP in terms of neonatal respiratory measures; our long-term follow-up of the original trial participants also suggests no evidence of disadvantage, in terms of long-term disability or psychological outcomes, from the use of CNEP."

This week there are four Comments to accompany this paper including a response from two of the original CNEP trial investigators, David Southall and Martin Samuels, and one from Alan Craft, President of the Royal College of Paediatrics and Child Health.

In an accompanying EditorialThe Lancet states: "This drawn-out process has been hugely damaging to the researchers, whose careers have been put on hold for considerable lengths of time, and to the parents of the children enrolled, anxious to know whether their children received the best possible care. But perhaps most importantly of all for children, the long-term health of paediatric research in the UK has been seriously damaged because the Government failed to bring this case to a close in a timely manner."

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Article adapted by Medical News Today from original press release.
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Contact: Professor N Marlow, Academic Division of Child Health, School of Human Development, Queen's Medical Centre, Nottingham NG7 2UH, UK. T) 0115 823 0605 neil.marlow@nottingham.ac.uk

Notes to editors
*Paediatrics 1996; 98: 1154-60

In the late 1990s, the UK Department of Health asked Rod Griffiths to investigate whether David Southall, Martin Samuels, and their colleagues had done a clinical trial in newborn infants with respiratory distress syndrome according to best practice. One of the recommendations of the Griffiths inquiry, published in May, 2000, was that the children should be followed up to determine whether CNEP is more harmful than conventional therapy.

Contact: Joe Santangelo
j.santangelo@elsevier.com
Lancet