Skip to content

Understanding the healthcare burden of illness in moderate-, late-preterm and term neonates: pilot stages

Understanding the healthcare burden of illness in moderate-, late-preterm and term neonates: pilot stages

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN93051761
Enrollment
630134
Registered
2024-02-16
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal care provision in moderate-, late-preterm, and term neonates Pregnancy and Childbirth

Interventions

Epidemiological descriptive study The background characteristics of admitted neonates will be described (including maternal, neonatal, and organisational factors) as will neonatal core outcomes. Data

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. For the descriptive study, the following population will be included: Neonates born after 32+0 weeks+days postmenstrual age between 1st January 2015 and 31st December 2021 and admitted to a neonatal unit in England and Wales). 2. For the stakeholder engagement project, the inclusion criteria will differ for the different stages. 3. For the focus groups participants will include former neonates born after 32+0 weeks+days, parents (including mothers, fathers, parents of admitted neonates, and parents of neonates who did not require admission), healthcare professionals, and representatives of wider society without direct personal experience of neonatal care. Participants will be selected purposively to include a broad range of backgrounds (including a range of ethnicities, educational statuses, and degrees of deprivation). 4. For the online survey participants will include former neonates born after 32+0 weeks+days, parents (including mothers, fathers, parents of admitted neonates, and parents of neonates who did not require admission), healthcare professionals, and representatives of wider society without direct personal experience of neonatal care. 5. For the in-depth interviews, individuals will be identified who did not feel that the use of data linkage was appropriate during the online survey. Cases will be purposively identified to provide a range of backgrounds.

Exclusion criteria

Exclusion criteria: 1. For the descriptive study, no neonates will be actively excluded. 2. For the stakeholder engagement project, no individuals will be actively excluded.

Design outcomes

Primary

MeasureTime frame
Descriptive epidemiological study measured using de-identified data held in the National Neonatal Research Database (NNRD): Survival to discharge home, defined as recorded as alive at final neonatal unit discharge Stakeholder engagement project: Qualitative data answering the following research question: Is it acceptable to former patients, parents, and wider society to link perinatal, childhood health, and education data without explicit consent (for the proposed neoOUTCOMES research project), measured using an online survey completed by stakeholders at one time point between September 2024 and January 2025

Secondary

MeasureTime frame
For the descriptive study the secondary outcomes are the following components of the neonatal core outcomes set: 1. Late-Onset Sepsis; defined in line with the Royal College of Paediatrics and Child Health National Neonatal Audit Programme (NNAP) definition “pure growth of a pathogen from blood” or “pure growth of a skin commensal” or a “mixed growth” after the first 72 hours of life and extracted from daily data at neonatal unit discharge 2. Necrotising enterocolitis; defined using the NNAP definition and extracted from daily data at neonatal unit discharge 3. Brain injury on imaging; defined in line with the UK Department of Health definition of neonatal brain injury and extracted from daily data at neonatal unit discharge 4. Retinopathy of prematurity; defined as a record of any retinopathy of prematurity on routine screening in the National Neonatal Dataset “retinopathy of prematurity ad-hoc form” and extracted from daily data at neonatal unit discharge 5. Bronchopulmonary dysplasia; defined using the NNAP definition of significant bronchopulmonary dysplasia and extracted from daily data at neonatal unit discharge 6. Blindness; defined as an answer of Yes to the question “Does this child have a hearing impairment?” on the NNAP form and extracted from data at 2 year (corrected age) review 7. Deafness; defined as an answer of Yes to the question “Does this child have a hearing impairment?” on the NNAP form and extracted from data at 2 year (corrected age) review 8. Ability to walk; defined as an answer of Yes to the question “Is this child unable to walk without assistance?” on the NNAP form and extracted from data at 2 year (corrected age) review For the stakeholder engagement project, the secondary outcomes will include qualitative data addressing the following research questions, measured using online surveys and interviews completed by stakeholders at one time point between September 2024 and January 2025: 1. What are the perspectives of former

Countries

England, United Kingdom

Contacts

Public ContactJames Webbe
james.webbe@nhs.net+44 (0)2033153157

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026