Trials / Completed
CompletedNCT03381027
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 408 (actual)
- Sponsor
- University College Cork · Academic / Other
- Sex
- All
- Age
- 37 Weeks – 42 Weeks
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
See study protocol attached.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Baby Massage | Structured massage of the baby |
Timeline
- Start date
- 2017-06-05
- Primary completion
- 2019-12-16
- Completion
- 2020-06-09
- First posted
- 2017-12-21
- Last updated
- 2020-10-28
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT03381027. Inclusion in this directory is not an endorsement.