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

Study Overview
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Brief Summary
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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
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See study protocol attached.

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

Conditions
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Sleep, Neurodevelopmental Disorders

Intervention / Treatment
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* Procedure: Baby Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born > 37 weeks gestation Single births Not requiring admission to the Neonatal Unit Healthy infants without suspected congenital or metabolic anomalies Exclusion Criteria: Infants born < 37 weeks gestation Multiple births Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.

Ages Eligible for Study
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Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm- Baby Massage<br>Interventional Arm= Baby Massage | Procedure: Baby Massage<br>* Structured massage of the baby<br>|
| No Intervention: Control Arm- no Baby Massage<br>Control Arm= no Baby Massage | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant sleep measured by video EEG length of sleep cycles | Sleep EEG | assessment carried out in fourth month of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-development measured by Griffiths 3 Developmental Assessment | Griffiths 3 Developmental Assessment | Assessment carried out at 4 & 18 month of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Sleep, Baby Massage, Neurodevelopmental Disorders