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

Sleep Clinical Trial

— BabySMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381027
• Other study ID #: GB02/17UCC
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: June 9, 2020

Study information

• Verified date: October 2020
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See study protocol attached.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: June 9, 2020
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Weeks to 42 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Neurodevelopmental Disorders
• Sleep

Intervention

Procedure:
• Baby Massage
Structured massage of the baby

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Cork	Munster

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant sleep measured by video EEG length of sleep cycles	Sleep EEG	assessment carried out in fourth month of life
Secondary	Neuro-development measured by Griffiths 3 Developmental Assessment	Griffiths 3 Developmental Assessment	Assessment carried out at 4 & 18 month of life