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

NCT03381027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2020-10-28

No results posted yet for this study

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.

Conditions

  • Sleep
  • Neurodevelopmental Disorders

Interventions

PROCEDURE

Baby Massage

Structured massage of the baby

Sponsors & Collaborators

  • University College Cork

    lead OTHER

Principal Investigators

  • Geraldine Boylan, PhD · INFANT UCC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2019-12-16
Completion
2020-06-09

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381027 on ClinicalTrials.gov