An interventional study of Baby Massage in Sleep and Neurodevelopmental Disorders, sponsored by University College Cork. Completed at 1 site in Ireland. Open to participants aged 37 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by University College Cork · Not applicable, Interventional, and Basic science
It is well known that sleep is essential for brain development and learning. Infants require extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for optimizing physical growth. It is also essential for brain plasticity; the genetically determined ability of the infant brain to change its structure and function in response to the environment. Studies in young animals have shown that sleep deprivation leads to increased programmed cell death, smaller brain size, and loss of brain plasticity, all of which have negative long-term impact on behaviour and learning ability.
Infant massage, a form of systematic tactile stimulation by human hands, improves sleep hygiene. Very little is known about how massage influences early brain development but it is certainly linked to the theory of environmental enrichment, which has been well established in animal models.
The aim of this project is to optimise the infant's sensory experience through a multi-sensory enrichment programme, including massage (a massage utilising a scented lotion before sleep each day), to encourage more structured sleep and ultimately show improved developmental and cognitive outcomes.
See study protocol attached.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's enrollment of 408 is above the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Interventional Arm= Baby Massage
Procedure: Baby Massage
Control Arm= no Baby Massage
Structured massage of the baby
Infant sleep measured by video EEG length of sleep cycles
Sleep EEG
Time frame: assessment carried out in fourth month of life
Neuro-development measured by Griffiths 3 Developmental Assessment
Griffiths 3 Developmental Assessment
Time frame: Assessment carried out at 4 & 18 month of life
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jun 2017 to primary completion in Dec 2019, 30 months.
Of 142 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 30 months is close to that.
Counting every sponsor, half of 148 studies reached it within 30 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Neurodevelopmental Disorders →