BABY SMART (Study of Massage therapy, sleep And neurodevelopMenT)
Research type
Research Study
Full title
BABY SMART (Study of Massage therapy, sleep And neurodevelopMenT)
IRAS ID
230364
Contact name
Ronit Pressler
Contact email
Sponsor organisation
University College Cork
Duration of Study in the UK
1 years, 4 months, 18 days
Research summary
The BABY SMART study will examine the effect of massage, delivered by parents according to a structured programme following training, on both the quality and quantity of sleep and on subsequent neurodevelopment. \n\nHealthy infants (born > 37 weeks, without suspected congenital or metabolic anomalies) will be recruited in the first week of life and once recruited to the study they will be randomly assigned to either the massage intervention group or the control (no-massage intervention) group. \n\nInfants in both the massage intervention and control groups will be asked to keep a record of when their infant sleeps. At the 4 month appointment, infants will have a video electroencephalogram (EEG) recorded while they take sleep. We will also carry out a developmental assessment (Griffiths III) at the 4 months and at 18 months appointments. At all appointments we will take some measurements of weight and height and ask some questions \n\nThe massage intervention group will receive training in infant massage at the 2 week appointment and will be asked to massage their baby 3 times a day for approx. 15 minutes until they return for the 4 month appointment about lifestyle, environment, general health, feeding and sleep.\n\nA subsection of the BabySMART study will also participate in the GentleTouch study which aims to record the effect of pleasant touch on a healthy infant using Somatosensory Evoked Potentials (SSEP) at 4 weeks and then at 4 months of age. \n\nThe study will be carried out at University College London.\n\n
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/2016
Date of REC Opinion
18 Dec 2017
REC opinion
Unfavourable Opinion