PREMII Psychometric Validation
Research type
Research Study
Full title
Prospective Psychometric Validation of the PREMature Infant Index (PREMII)
IRAS ID
238905
Contact name
Hannah Lewis
Contact email
Duration of Study in the UK
0 years, 10 months, 3 days
Research summary
Is the electronic premature infant index (PREMII) valid for nurses to assess functional status of premature infants?
The PREMII has been developed for use on an electronic device (SitePad) to assess the functional status of premature infants in neonatal units (NNU). This study will test whether the PREMII is valid for use by nurses. This is done because the PREMII will be used in a future trial to evaluate a medicine (SHP607), which may prevent chronic lung disease in premature infants. The current study is sponsored by Shire Pharmaceuticals, a medicines manufacturer.
Premature infants in the NNU and their treating nurses and doctors will be included. The parents/guardians will be invited and given the study information and consent form by their nurse or doctor. Parents will be given time to consider taking part and to ask questions before consent is given.
Inclusion criteria:
• Infant born between gestational age of 23 weeks + 0 days and 27 weeks + 6 days
• Parent/guardian able to provide written informed consentExclusion criteria relate to comorbidities and plans to transfer the infant to another hospital.
The PREMII will be completed by the NNU nurse responsible for the infant near the end of her shift. The doctor will complete 16 questions related to functional status using pen-and-paper at the end of the morning round. The nurse will also complete the Infant Clinical Characteristics Form upon discharge (or turning week 40), and each participating nurse and doctors will also complete the Nurse Characteristics Form and Physician Characteristics Form.
One NNU site in the United Kingdom (UK) and one in the United States of America (US) will take part to recruit 50 infants in total. A research ethics board in the US will review the study for the US site.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0073
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion