COSYBABY - RCT to improve very preterm babies' physiologic stability

• Research type

  Research Study

• Full title

  A preliminary randomised controlled trial to improve physiological stability of very preterm babies.

• IRAS ID

  266587

• Contact name

  Suzan Jeffries

• Contact email

  s.jeffries@imperial.ac.uk

• Sponsor organisation

  Chelsea and Westminster Hospital NHS Foundation Trust

• Duration of Study in the UK

  1 years, 11 months, 27 days

• Research summary

  Babies born very preterm (more than 8 weeks before their due date) are immature. This makes their breathing and heart rate unstable. One way in which this is manifest is episodes of apnoea, which means “forgetting” to breathe for a few seconds. This can be accompanied by a drop in oxygen level and a fall in heart rate. The aim of this study is to evaluate whether the Babybe, a new, clinically tested soft-robotics medical device that records the mother’s heart-beat and breathing movements so that baby can feel these even when she is not present, can reduce the frequency of episodes of apnoea in very preterm babies.
  In this preliminary study we will compare the number of episodes of apnoea in very preterm babies cared for in the Chelsea & Westminster neonatal unit while lying on a Babybe mattress that is ‘active’, i.e. transmitting mother’s heart beat and breathing movements with the number of episodes during routine care. Each baby will spend 12 hours/day for 5 days on the Babybe mattress. Babies will be randomly allocated to one of 4 sequences: ABABABABAB (morning shift 8:00 am start); BABABABABA (morning shift 8:00 am start); ABABABABAB (night shift 8:00 pm start); BABABABABA (night shift 8:00 pm start); where A is standard care mattress and B is Babybe. In this way we will answer the question: “Does using the Babybe, compared to standard care, reduce the frequency of apnoea of prematurity? We will also obtain parent and staff feedback about the Babybe and taking part in research.

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  20/LO/0205

• Date of REC Opinion

  25 Mar 2020

• REC opinion

  Further Information Favourable Opinion