Clinical Trials Directory

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

TypeNameDescription
PROCEDUREBaby MassageStructured 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.