SHINES

• Research type

  Research Study

• Full title

  An observational physiological study preterm infants at 30-32 weeks gestation using Salivary Hormones to Investigate Neonatal Exposure to Steroids (SHINES)

• IRAS ID

  349538

• Contact name

  Colin Morgan

• Contact email

  colin.morgan@lwh.nhs.uk

• Sponsor organisation

  Liverpool Women's Hospital

• Duration of Study in the UK

  1 years, 2 months, 31 days

• Research summary

  The SHINES study is an observational physiological study of preterm infants at 30-32 weeks gestation, using salivary hormones to investigate neonatal exposure to steroids.
  The study invites parents who have a child born aged 30 to 32+6 gestation and parents whose child was born at <27 weeks gestation when their baby turns 30 weeks corrected gestation. These babies will have salivary samples collected throughout their NICU stay and sent to a specialist laboratory, where the samples will be analysed.
  The study aims to produce robust normative data for use in clinical practice. We also aim to compare salivary cortisol and cortisone profiles for those born extremely preterm (<27 weeks) compared to moderately pre-term infants (30 – 32 weeks inclusive), whilst also collecting data to determine foetal androgen profiles.

  Cortisol is our primary stress hormone, produced by the adrenal glands. In the UK, administering steroids to preterm babies- antenatally and postnatally-is a common practice in neonatal care units. However, giving steroid medication to these infants may potentially influence their natural hormone production, both in the short and long term. By comparing groups of preterm infants at the same gestational age—extreme preterm babies being exposed to postnatal steroids—we can assess whether postnatal steroid treatment impacts the babies' own hormone production.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  25/NE/0016

• Date of REC Opinion

  31 Jan 2025

• REC opinion

  Favourable Opinion