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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03381027
Acronym
BabySMART
Enrollment
408
Registered
2017-12-21
Start date
2017-06-05
Completion date
2020-06-09
Last updated
2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental Disorders, Sleep

Keywords

Infant Sleep, Baby Massage, Neurodevelopmental Disorders

Brief 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.

Interventions

PROCEDUREBaby Massage

Structured massage of the baby

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

Neurodevelopmental assessors are blinded to interventional arm.

Intervention model description

single centre, unblinded, randomised, controlled study to evaluate whether a multi-sensory enrichment programme in the first 4 months of life will improve sleep architecture and neurodevelopment in healthy infants.

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
Yes

Inclusion criteria

1. Infants born \> 37 weeks gestation 2. Single births 3. Not requiring admission to the Neonatal Unit 4. Healthy infants without suspected congenital or metabolic anomalies

Exclusion criteria

1. Infants born \< 37 weeks gestation 2. Multiple births 3. Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.

Design outcomes

Primary

MeasureTime frameDescription
Infant sleep measured by video EEG length of sleep cyclesassessment carried out in fourth month of lifeSleep EEG

Secondary

MeasureTime frameDescription
Neuro-development measured by Griffiths 3 Developmental AssessmentAssessment carried out at 4 & 18 month of lifeGriffiths 3 Developmental Assessment

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026