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

Not Applicable

Completed

• Conditions: Sleep; Neurodevelopmental Disorders
• Interventions: Procedure: Baby Massage

• Registration Number: NCT03381027
• Lead Sponsor: University College Cork

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.

Study Timeline

• Study Start: 2017-06-05
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Primary Completion: 2019-12-16
• Study Completion: 2020-06-09
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Arm- Baby Massage	Baby Massage	Interventional Arm= Baby Massage

Primary Outcome Measures

Name	Time	Method
Infant sleep measured by video EEG length of sleep cycles	assessment carried out in fourth month of life	Sleep EEG

Secondary Outcome Measures

Name	Time	Method
Neuro-development measured by Griffiths 3 Developmental Assessment	Assessment carried out at 4 & 18 month of life	Griffiths 3 Developmental Assessment

Trial Locations

Locations (1)

Cork University Maternity Hospital; 🇮🇪 Cork, Munster, Ireland