[Show abstract][Hide abstract] ABSTRACT: The outcome in late childhood for children entered into a randomised trial of continuous negative extrathoracic pressure (CNEP) versus standard respiratory management for the treatment of neonatal respiratory distress was studied. In the original trial, there were advantages in the duration of oxygen and the prevalence of chronic lung disease for those assigned to receive CNEP.
To determine whether the above differences had persisted into childhood.
Outpatient evaluation of children by a paediatrician using Spirometry (Vitalograph Spirometer 2120, Ennis, Ireland) and MicroRint (Micro Medical, Rochester, Kent, UK) techniques independently of the original trial. Parents completed questionnaires about their child's respiratory history and social-demographic information.
133 (65%) survivors were evaluated at 9.6-14.9 years of age. The group examined were representative of the original cohort and no significant baseline differences were observed between children evaluated who had been allocated to CNEP or standard treatments. We compared Rint (before and after bronchodilator) and forced expiratory flow, volume and vital capacity between the two study groups; none were significant. Children in the standard group had received paediatric intensive care more often (p = 0.19) and were more likely to be receiving inhaled drugs for asthma (p = 0.19; all not significant).
No important differences were found at follow-up in late childhood in respiratory outcomes for children treated with neonatal CNEP or standard treatment. Caution should be exercised, as the original trial was not powered to show these differences, but there seems to be no long-term detriment in respiratory outcomes for children treated with CNEP in the neonatal period.
Archives of Disease in Childhood - Fetal and Neonatal Edition 02/2007; 92(1):F19-24. · 3.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A previous randomised trial of continuous negative extrathoracic pressure (CNEP) versus standard treatment for newborn infants with respiratory distress syndrome raised public concerns about mortality and neonatal morbidity. We studied the outcome in late childhood of children entered into the trial to establish whether there were long-term sequelae attributable to either mode of ventilation.
Outpatient assessment of neurological outcome, cognitive function, and disability was done by a paediatrician and a psychologist using standardised tests. 133 of 205 survivors from the original trial were assessed at 9-15 years of age. Of the original pairs randomly assigned to each ventilation mode, the results from 65 complete pairs were available. The primary outcome was death or severe disability.
Primary outcome was equally distributed between groups (odds ratio for the CNEP group 1.0; 95% CI 0.41-2.41). In unpaired analysis there was no significant difference between treatment modalities (1.05; 0.54-2.06). Full IQ did not differ significantly between the groups, but mean performance IQ was 6.8 points higher in the CNEP group than in the conventional-treatment group (95% CI 1.5-12.1). Results of neuropsychological testing were consistent with this finding, with scores on language production and visuospatial skills being significantly higher in the CNEP group.
We 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.
The Lancet 05/2006; 367(9516):1080-5. · 39.21 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Research has a central role in clinical governance, and basic or applied research underpins most aspects of our clinical practice. This article uses the framework of a typical research protocol to describe the important steps involved in planning research. This includes identification of a suitable topic, selection of an appropriate research question, study design and methodology. Key to achieving a good research plan is preparation and organization.