Retrospective Validation of the PREMII using a Real-world Database V1
Research type
Research Study
Full title
Retrospective Validation of the PREMature Infant Index (PREMII) using a Real-World Database
IRAS ID
242377
Contact name
Michael Cook
Contact email
Sponsor organisation
Shire Plc
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Reducing length of stay in hospital for extremely premature infants may be considered an important outcome. Length of stay is impacted by whether an infant’s overall health and functional status have improved to allow discharge from the hospital in the opinion of the infant’s treating paediatrician. The PREMature Infant Index (PREMII) is a clinician-reported tool developed for use on an electronic device to measure an infant’s overall functional status on each day of a stay in the hospital. This study aims to validate the PREMII in a representative sample of premature infants in a real-world setting. The current study is sponsored by Shire Human Genetic Therapies, a medicines manufacturer.
A retrospective database analysis will be conducted using data from the UK's National Neonatal Research Database.
Inclusion criteria:
Infants who are less than 28 weeks of gestational age upon admission to the neonatal intensive care unit and have complete data on demographics (i.e. month and year of birth, birth weight, gestational age and sex), and admission and discharge details (anonymised date and time)Exclusion criteria:
Infants with congenital heart diseases, congenital diaphragmatic hernia, or congenital malformations.Infants identified for inclusion from the database will be followed from birth to discharge from the hospital. Data will be analysed to examine infant's overall function status measured using the PREMII and evaluate the predictive validity of the PREMII with an infant's length of stay in the hospital.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1619
Date of REC Opinion
21 Sep 2018
REC opinion
Favourable Opinion