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

University College Cork (UCC)

Status: Completed

Conditions: Neurodevelopmental Disorders; Sleep

Treatments: Procedure: Baby Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT03381027

GB02/17UCC

Details and patient eligibility

About

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.

Full description

See study protocol attached.

Enrollment: 408 patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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408 participants in 2 patient groups

Interventional Arm- Baby Massage

Experimental group

Description:

Interventional Arm= Baby Massage

Treatment:

Procedure: Baby Massage

Control Arm- no Baby Massage

No Intervention group

Description:

Control Arm= no Baby Massage