Core Outcome Measures in Effectiveness Trials

Core Outcomes in Neonatology (COIN)

General Information

One in eight UK babies require some form of neonatal care, over 80,000 infants annually. 40% of all deaths in childhood occur in the neonatal period and neonatal conditions are a leading cause of life-long morbidity. Neonatal research to date has reported multiple different outcomes and outcome measures. This variation limits the combination and comparison of individual studies, limiting their usefulness in informing and influencing clinical practice

The aim of this study is to develop a neonatal Core Outcome Set that are linked to data that are routinely recorded during clinical care. Development and use of a core outcome set will ensure that outcomes of importance to all stakeholders, including patients and parents, are collected and reported in a standard way.

Embedding a core outcome set collected from routine clinical data within future clinical studies will advance the usefulness of research to inform practice with minimal addition burden, enhance patient care and improve outcomes.

Lead Investigator
Dr James Webbe
ST4 in Paediatrics
Imperial College, London

Professor Neena Modi
Professor of Neonatal Medicine
Imperial College London

Dr Chris Gale
Senior Clinical Lecturer in Neonatal Medicine
Imperial College London

Further Study Information

Current Stage:
Completed – pending publication
January 2016 - March 2018
Funding source(s):

Health Area

Disease Category
Neonatal care

Disease Name

Target Population

Age Range
0 - 0


Nature / type of Intervention


Delphi process
Literature review
Systematic review

A steering group including neonatal, paediatric and nursing healthcare professionals, researchers, parents and patients will be formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review of clinical trials and a systematic review of qualitative data sources, parent outcomes will be extracted from these existing qualitative data sources. Potential core outcomes will be matched with routinely collected data items and will be entered into an international, multi-perspective Delphi survey. All stakeholders, including healthcare professionals, researchers, and patients will be invited to participate.

Stakeholder groups invovled:
Clinical experts
Patient/ support group representatives
Service users
Additional or other:
1. Parents of neonatal patients
2. Ex-neonatal unit patients
3. Neonatologists from Special Care Baby Units, Local Neonatal Units and Neonatal Intensive Care Units
4. Academics active in the field of neonatology
5. Neonatal nurses
6. Representatives from the National Neonatal Audit Project (NNAP)
7. Representatives from the commercial provider of neonatal electronic patient record systems, Clevermed

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Patient/ support group representatives
Service users

Study Type

COS for clinical trials or clinical research
COS for practice

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.