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Policy Research Programme - Improving the optimisation and stabilisation of the preterm infant

Published

14 December 2021

Version

1.0 - December 2021

Contents

Timetable and budget

DescriptionDeadline/Limit  
Deadline for Stage 1 Applications 18 January 2022, 1 PM
Notification of outcome of Stage 1 Application March 2022
Deadline for Stage 2 application 03 May 2022, 1 PM
Notification of Stage 2 Application August 2022
Project Start September 2022
Budget £350,000 for a single project

Introduction 

1. The NIHR Policy Research Programme (PRP) invites applications for a single research project to undertake a qualitative evaluation of the national implementation of a seven element care pathway focused on improving the optimisation and stabilisation of the preterm infant. 

Background 

2. Babies that are born preterm (especially those born before 34 weeks), contribute significantly to the overall neonatal death and brain injury rates in England. In addition, prematurity is the most significant contributor to infant mortality. The Maternity Transformation Programme (MTP) is supporting a national ambition to reduce these significant harms alongside reductions in stillbirth rates, maternal mortality and preterm birth.

3. The Maternity and Neonatal Safety Improvement Programme (MatNeoSIP) is a national safety improvement programme that is directly supporting the work of the MTP across England. It has been supporting all maternity and neonatal providers across England since 2017. It currently has three key workstreams focusing on increasing the proportion of smoke-free pregnancies, improving the detection and management of deterioration of the pregnant mother and newborn and improving the optimisation and stabilisation of the preterm infant. 

4. As part of the optimisation and stabilisation of the preterm infant workstream MatNeoSIP has developed a seven-element care pathway in partnership with key stakeholders (including the British Association of Perinatal Medicine, The Royal College of Obstetricians and Gynaecologists, The Royal College of Midwives and academic partners). This pathway addresses a range of key interventions for both the mother and her baby from the point of attending in preterm labour up to and including the immediate period following admission to the neonatal unit. The pathway has been finalised and Trusts across England are now working on a range of the individual elements. We plan for all organisations to be working on all elements of the pathway by April 2022. This activity will be measured through increasing reliability of the processes. The individual interventions are listed below:

Place of Birth: Extreme preterm birth in a tertiary unit setting significantly improves survival and neurodevelopmental outcomes.
Objective: All Singleton infants less than 27 weeks of gestation and all multiples less than 28 weeks of gestation should be born in a maternity service on the same site as a neonatal intensive care unit (NICU).

Antenatal Steroids: The use of antenatal steroids significantly improves survival by reducing the risk of preterm lung disease, brain haemorrhage, necrotising enterocolitis (NEC) and sepsis.
Objective: All women giving birth less than 34 weeks of gestation, should receive a full course of antenatal steroids no longer than 7 days prior to birth, and ideally within 24-48 hours.

Magnesium Sulphate: The use of magnesium sulphate within 24 hours prior to birth significantly reduces the risk of cerebral palsy.
Objective: All women giving birth less than 30 weeks of gestation, should receive antenatal magnesium sulphate within the 24 hours prior to birth.

Intrapartum Antibiotics: The use of antibiotics 4 hours before birth significantly improves survival outcomes by reducing the risk of Group B Streptococcus sepsis
Objective: All women in established preterm labour less than 34 weeks of gestation should receive intrapartum antibiotic prophylaxis at least 4 hours before birth.

Optimal Cord Management: Optimal cord management significantly improves survival by reducing the risk of brain haemorrhage as well as the need for blood transfusion
Objective: All eligible babies less than 34 weeks gestational age should not have their umbilical cord clamped for at least 60 seconds after birth. 

Normothermia: Early hypothermia (<36.5°C) increases the risk of mortality and brain haemorrhage, NEC and sepsis. Emerging evidence links early hyperthermia (>38°C) to adverse outcomes
Objective: All eligible babies less than 32 weeks gestational age should have a first temperature on admission between 36.5 - 37.5°C and measured within an hour of birth.

Maternal Breast Milk: The safest milk for preterm babies is maternal breast milk as it significantly improves survival by reducing the risk of sepsis and NEC
Objective: All babies less than 34 weeks gestational age should receive maternal milk within 6 hours of birth.

5. There is well documented evidence that achieving high reliability for each of these seven interventions improves outcome [1-4]. This works aims to demonstrate that in addition to increasing reliability in these individual interventions at national level, there are added improvements in outcome when all of the relevant interventions are undertaken for each mother and baby.

6. For all these interventions there is a need for effective pathways of care within and between clinical teams and organisations within clinical systems. MatNeoSIP, through partnership working with key stakeholders (patient safety collaboratives, maternity clinical networks and neonatal operational delivery networks), will provide improvement and measurement support for the implementation of the pathway. This will involve Trust level quality improvement coaching and engagement in local patient safety networks. MatNeoSIP have developed a detailed measurement plan which includes all the process measures for each of the seven interventions as well as composite process measures and associated clinical outcomes. We would expect the successful applicants to coordinate with the MatNeoSIP team who will be coordinating a quantitative evaluation of the pathway.  

7. The spread and adoption of this pathway will provide vital support for realising the national ambition of the MTP. It will be key to understand how clinical teams work together across the health care system to inform future work in this area and for other national improvement initiatives within maternity and neonatal care.

8. There are regional differences in how organisations work together to make decisions about the optimisation and stabilisation of the preterm infant. 

9. Some women are required to move between organisations at times of extreme stress and concern. Additionally, the impact of caring for these women and babies can be very significant on the staff involved. 

Research priorities

The specific aims of this research will be:

10. To explore how multiple clinical teams work together (within and between organisations) to make decisions about the optimisation and stabilisation of the preterm infant for the entire pathway (including all seven elements)

  • Understanding potential barriers and facilitators to effective working within and between organisations 
  • Understanding how and when decisions are made
  • Exploring variation between different systems 

11. To explore the experiences of care that women and families receive through this pathway and the experiences of staff caring for women and families 

  • Understanding how women and families are informed about decisions about their care
  • Exploring the impact of these decisions on their experience of care
  • Exploring the impact on staff of caring for pre-term infants, women and families 

Areas out of scope for this programme of work

12. The MatNeoSIP programme will track the impact of the pathway through a detailed measurement strategy. This will involve singular process measures, composite process measures and clinical outcomes. Therefore, a quantitative evaluation of the programme will not be required through this research.

Outputs 

13. Expected outputs include:

  • Policy-tailored briefings to explain key findings to policy officials.
  • An interim report and presentation highlighting initial findings and progress, followed by a meeting with officials.
  • A final report.

14. Applicants are asked to consider the timing and nature of deliverables in their proposals. Policymakers will need research evidence to meet key policy decisions and timescales, so resource needs to be flexible to meet these needs. A meeting to discuss policy needs with DHSC officials will be convened as a matter of priority following contracting. 

Budget and duration

15. A budget of £350,000 is available for this research over the period of 18 months starting no later than September 2022.  

16. The duration of the research and individual projects within the contract will be no longer than is consistent with high quality studies. In assessing proposals, the Department will be seeking value for money as well as scientific excellence and, in particular, the potential for policy impact which is key.

17. Applicants are asked to address the timing and nature of deliverables, maximising staff. 

18. Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.

Management arrangements

19. A research advisory group including, but not limited to, representatives of DHSC, National Maternal and Neonatal Safety Improvement Programme, British association of perinatal medicine, Royal college of Obstetricians and Gynaecologists, Royal College of Midwives, and the successful applicants for the research should be established. The advisory group will provide guidance, meeting regularly over the lifetime of the research. The successful applicants should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. They will be expected to:

  • Provide regular feedback on progress
  • Produce timely reports to the advisory group
  • Produce a final report for sign off

20. Research contractors will be expected to work with nominated officials in DHSC, its partners and the NIHR. Key documents including, for example, research protocols, research instruments, reports and publications must be provided to DHSC in draft form allowing sufficient time for review.

References

  1. Antenatal Optimisation Toolkit
  2. Normothermia Toolkit
  3. Maternal Breast Milk Toolkit
  4. Optimal Cord Management Toolkit

Key documents