Southall's CNEP trial more than stands up to scrutiny

Abstract

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. Some parents had alleged that the trial was poorly supervised and that they had not given informed consent for their children to be enrolled in the study, which compared continuous negative extrathoracic-pressure ventilation (CNEP) with standard treatment. One of the recommendations of the highly controversial Griffiths inquiry, published in May, 2000, was that the children should be followed up to determine whether CNEP is more harmful than conventional therapy. Katherine Telford and colleagues, who had no role in the original trial, were commissioned to assess the long-term data from the children, who are now aged 9–15 years. The results of their study are presented in this week's Lancet. They conclude that there is no evidence of poorer long-term outcome after CNEP than standard treatment. Telford and colleagues' study, together with Edmund Hey's and Iain Chalmers' earlier assessment of the CNEP trial in the BMJ in 2000, prove that the trial methodology was sound; indeed, in many ways it was ahead of its time. As Rod Griffiths notes in a Comment, David Southall and the other investigators should be congratulated on their trial, which has stood up to the closest of scrutiny. It is a sad indictment of the UK's research oversight process that it has taken so long to vindicate Southall and colleagues. Some parents still maintain that they never gave informed consent for their children to be enrolled, although the GMC, the local hospital, and the police have all investigated the claims. Importantly, however, the Department of Health has never attempted to answer the criticisms of the Griffiths' report. 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. Are any of the criticisms of the CNEP trial true?“Parents were misled over hospital trials that killed premature babies” Full-Text PDF CNEP needs to returnWe welcome the findings of the study by Katherine Telford and colleagues1 in today's Lancet about the absence of evidence of harm to the long-term neurodevelopmental outcome of preterm infants treated with continuous negative extrathoracic pressure (CNEP) in our randomised trial. Support for babies and young children with respiratory failure is usually achieved by intubation and positive pressure ventilation. However, this approach can damage the immature lung, increases the risk for secondary infection, and needs analgesia or sedation. Full-Text PDF Southall and colleagues vindicated once moreThe pioneering research of David Southall and colleagues1–4 has been subjected to unprecedented scrutiny. Southall's work has often been at the cutting edge of knowledge and he has ventured into areas that are inherently controversial. He has made many important contributions to the published literature and many lives have undoubtedly been saved by his research. Full-Text PDF CNEP and research governanceRepeated headlines about baby deaths associated with experimental treatment—continuous negative extrathoracic pressure (CNEP)—attracted the attention of Members of Parliament. Their pressure on Ministers led to the question, “Could there be a problem with the system?” and this led to the review1 I chaired. Matters were further complicated when groups of parents insisted on child protection issues being considered, but they have no place here. Full-Text PDF Outcome after neonatal continuous negative-pressure ventilation: follow-up assessmentWe saw no evidence of poorer long-term outcome after neonatal CNEP whether analysis was by original pairing or by unpaired comparisons, despite small differences in adverse neonatal outcomes. The experience of our study indicates that future studies of neonatal interventions with the potential to influence later morbidity should be designed with longer-term outcomes in mind. Full-Text PDF