NCT03381027: BabySMART

BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)

Completed NA Last updated 28 October 2020

What this trial tests

NA trial testing Baby Massage in Sleep in 408 participants. Completed in 9 June 2020.

Timeline

5 June 2017

Primary endpoint
16 December 2019

9 June 2020

Quick facts

Lead sponsor	University College Cork
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	408
Start date	5 June 2017
Primary completion	16 December 2019
Estimated completion	9 June 2020
Sites	1 location across Ireland

Drugs / interventions tested

• Baby Massage

Conditions studied

• Sleep — all drugs for Sleep →
• Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →

Sponsor

University College Cork

Who can join

Adults 37 Weeks to 42 Weeks, any sex, with Sleep or Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electroencephalographic sleep macrostructure and sleep spindles in early infancy.
   Ventura S, Mathieson SR, O'Toole JM, Livingstone V, et al · · 2022 · cited 11× · PMID 34755881 · DOI 10.1093/sleep/zsab262
2. Neurodevelopmental outcome of low-risk moderate to late preterm infants at 18 months.
   Ryan MA, Murray DM, Dempsey EM, Mathieson SR, et al · · 2023 · cited 10× · PMID 38098644 · DOI 10.3389/fped.2023.1256872
3. Infant sleep EEG features at 4 months as biomarkers of neurodevelopment at 18 months.
   Ventura S, Mathieson SR, O'Toole JM, Livingstone V, et al · · 2025 · cited 2× · PMID 39979586 · DOI 10.1038/s41390-025-03893-6
4. Reference centiles for infant sleep parameters from 4 to 16 weeks of age: findings from an Irish cohort.
   O Sullivan MP, Livingstone V, Korotchikova I, Dempsey EM, et al · · 2023 · PMID 36944485 · DOI 10.1136/archdischild-2022-324016