Title: Comparison of short and long term outcome of extremely preterm infants between two tertiary centres utilising different intervention thresholds for management of blood pressure
Funder: Department of Health (England)

Abstract: Background: Blood pressure (BP) is routinely monitored in all neonatal units, but the criteria for supporting low blood pressure vary widely. There is a wide range of opinion in neonatal care as to whether blood pressure is a parameter of marked importance, or one which is peripheral to the main aims of therapy. A number of trials have examined the drugs used to support blood pressure, but there have been no studies comparing outcomes in extreme preterm neonates at different blood pressure intervention levels. International review groups have identified this as a priority for research. Aim: The aim of the study is to compare the short term clinical and two year neurodevelopmental outcome of extreme preterm infants (23-28 weeks gestation) those who received two different thresholds of intervention to support BP. Questions to be answered: Primary outcome measures: Death or parenchymal brain abnormality on cerebral ultrasound scan before discharge home. Neurodevelopmental outcome at two years of age. Secondary outcome meaasures: Acquired gastrointestinal pathology (necrotising enterocolitis, perforation or GI surgery) Maximum serum creatinine in the first 2 weeks of life Use of inotropes and duration of their use Mean arterial blood pressure during the first three days after birth Maximum serum potassium level in the first two weeks of life Duration of neonatal care at each BAPM care level (this is the basis for charging for care and a good marker of health service costs) Methods This is a retrospective case notes review study comparing the outcomes of extreme preterm infants in two large tertiary perinatal centres in North East London (Homerton University Hospital and Royal London Hospital) based on the difference in thresholds of intervention to support blood pressure. Inclusion criteria All preterm infants (23-28 weeks gestation) admitted over 4 years from 01/01/07 to 31/12/10. Exclusion criteria Babies admitted after 12 hours of age (ex-utero transfers >12 hours) Babies with major congenital malformation Babies whose intensive care observational charts (to collect BP data) were not traceable Data collection Short term clinical outcome measures; pregnancy complications, condition of the baby at birth, demographics, blood pressure level and management for first 72 hours of life, complications of gastrointestinal tract (e.g. Nectrotising enterocolitits), brain ultrasound scan findings, death or discharge from the neonatal unit and data concerning British Association of Perinatal Medicine (BAPM) levels of care will be collected. Longterm neurodevelopmental outcome; neuromotor function (mobility and hand function), neurology (seizures, presence of shunt), developmental delay, neurosensory impairment (vision, hearing), communication (speech, understanding language), presence and type of cerebral palsy as well as information on respiratory, renal, cardiovascular and gastrointestinal health will be collected. Statistical Analysis Analysis will compare outcomes for the babies treated in the two hospitals according to the different blood pressure management plans. Adjustments will be made for all possible differences in confounders between these two hospitals. The association of the babies’ blood pressure with outcomes will be examined in order to provide evidence that it is the difference in blood pressure management between the two hospitals rather than other unspecified treatments that are affecting the outcomes.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR