Optimising neonatal service provision for preterm babies (27-31 weeks)
Research type
Research Study
Full title
OPTIPREM: Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation in England using national data, qualitative research and economic analysis.
IRAS ID
212034
Contact name
T Pillay
Contact email
Sponsor organisation
The Royal Wolverhampton NHS Trust
Clinicaltrials.gov Identifier
NCT02994849, Clinicaltrialsgov; 33299, ISRCTN
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
New evidence shows that for babies born at 23-26 weeks, care in one of two types of neonatal units, i.e a Neonatal Intensive Care unit (NICU) as opposed to a Local Neonatal Unit (LNU) improves survival to discharge: this is informing policy that shapes their services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born between 27-31 weeks) whose care is currently spread between 45 NICU and 84 LNU in England. This group accounts for 4 times more neonatal unit admissions than those born at 23-26 weeks, and 12% of all preterm births in England. They utilise twice as many NHS bed days/year compared to those born at 23-26 weeks, and over a third of all neonatal unit care days.
Our primary objective is to assess, for babies born at 27-31 weeks and admitted to a neonatal unit, whether care in a NICU vs a LNU impacts on survival and key morbidities (to age 1 year), at each gestational age in weeks. This will be achieved through analysis of routinely recorded data extracted from real-time, point-of-care patient management systems and held in the National Neonatal Research Database (NNRD),Hospital Episode Statistics (HES) and Office for National Statistics (ONS)for admissions over the period 01/01/14-31/12/17 in England.
Secondary objectives are whether differences in clinical care exist between LNU and NICU, and whether these are associated with gestation-specific differences in outcomes; where it is most cost-effective to provide care; and parents’ and clinicians' perspectives on place of care, and how these can guide clinical decision-making.
The information will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy making.http://www.royalwolverhampton.nhs.uk/research-and-development/opti-prem-improving-neonatal-service-delivery/
Lay summary of study results: Due to the limited recruitment of only four patients, it was not possible to draw meaningful conclusions or determine study outcomes. The small sample size significantly hindered the ability to meet the objectives of the study.
The initial recruitment target for the study was approximately 140 patients; however, due to early termination, we were only able to recruit a total of four patients. The study encountered significant challenges, primarily stemming from logistical constraints, limited resources, and insufficient support. These issues were exacerbated by the peak of the COVID-19 pandemic, which led to a suspension of all study activities. At that time, cardiac involvement in COVID-19 was just beginning to be reported, with its mechanisms largely speculative. For instance, it is now understood that myocardial inflammation resulting from COVID-19 is rare and may manifest some time after the acute infection. Consequently, the study design relied on incomplete and often speculative data emerging from early reports in Wuhan.
Although the study commenced early, regulatory and administrative delays prevented the start of this observational, non-interventional study until well after the first peak of the pandemic in the spring and summer of 2021. As a result, recruitment did not include patients from the first peak. Institutional issues during this period further contributed to these delays.
Following the first peak, portfolio adoption was sought to address anticipated recruitment challenges during a potential second peak, with the aim of securing CLRN support. While adoption was successful, recruitment assistance was unavailable at any of the four Barts Health sites due to capacity limitations and staff redeployment at the time.
Additionally, the success of the vaccination rollout has since rendered the foundational premises of the study obsolete.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0080
Date of REC Opinion
17 Mar 2017
REC opinion
Favourable Opinion