Description of the goods or services required
19/121 The clinical and cost effectiveness of pulse oximetry screening for hypoxaemia in newborn babies
The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.
Does newborn screening for hypoxaemia lead to improvements in the 28 day and 12 month clinical outcomes for babies and is it cost-effective?
1.Intervention: Pulse oximetry (PO) screening offered to non-symptomatic newborn babies.
2.Target group: Non-symptomatic newborn babies born after 36 weeks gestation.
3.Setting: Maternity services.
4.Comparator: Babies in maternity services that do not carry out pulse oximetry screening.
5.Study design: Applicants should propose an efficient data-enabled randomised study, or justify their rationale for an alternative design that overcomes the deficiencies of previous observational studies and is able to compare outcomes for the range of significant conditions associated with pulse oximetry screening in the first hours of life. The important conditions of interest should be pre-defined and the screening pathway, timing of testing and subsequent management for screen positive babies should be described. The study should be of sufficient size to enable the model of pulse oximetry screening to provide clear findings for the UK National Screening Committee.
The study should include an internal pilot phase to confirm the ability to recruit and to collect appropriate resource data on investigation and management of screened and unscreened babies.
6.Important outcomes: 28 day and 12 month morbidity (applicants to define).
Other outcomes: Cost-effectiveness; estimates of screening performance for significant cardiac and non-cardiac conditions; consequence of false positive screens, timeliness of diagnosis; 28 day and 12 month mortality; resource use; length of stay (hours/ days); parental acceptability.
7.Minimum duration of follow up: 28 days for full data, with routine data collected at 12 months.
Longer-term follow up: Researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
The UK National Screening Committee (UK NSC) has considered the use of pulse oximetry to identify babies at risk for critical congenital heart defects (CCHD) on a number of occasions.
The review undertaken for the National Screening Committee in 2014 presented evidence that pulse oximetry testing for hypoxaemia leads to an increase in the detection rate of critical congenital heart disease in newborn babies.
At that time, the National Screening Committee recommended that screening should not be introduced for critical congenital heart disease as there was insufficient evidence about the wider impact of pulse oximetry screening on healthy babies, parents and clinical services. A major gap in the evidence related to the impact of pulse oximetry screening on babies found to have other significant, non-symptomatic, non-cardiac conditions that may be indicated by hypoxaemia.
To try to explore the benefits and harms of pulse oximetry screening for both critical congenital heart defects and this wider range of conditions the National Screening Committee commissioned a pilot study and a cost-effectiveness evaluation from the Institute of Applied Health Research at Birmingham. However, this was unable to provide an estimate of the clinical or cost-effectiveness of screening as existing research had not provided appropriate comparator data. The National Screening Committee recently consulted stakeholders on this topic.
The consultation drew attention to the continuing clinical and public interest in the use of pulse oximetry for newborn screening and highlighted that a significant number of NHS Trusts carry out pulse oximetry testing on newborn babies. However, protocols and practice is varied.
With the high level of interest and spread of newborn pulse oximetry testing it has become increasingly important that a well-designed study is carried out to provide robust research evidence on the wider consequences, clinical impact and cost-effectiveness of screening for hypoxaemia in the newborn. Without this evidence the potential role for the test in the neonatal pathway will remain uncertain.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email email@example.com.