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

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

Sponsors

Lead sponsor: University College Cork

Source 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.

Overall Status Active, not recruiting
Start Date June 5, 2017
Completion Date May 2020
Primary Completion Date December 16, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Infant sleep measured by video EEG length of sleep cycles assessment carried out in fourth month of life
Secondary Outcome
Measure Time Frame
Neuro-development measured by Griffiths 3 Developmental Assessment Assessment carried out at 4 & 18 month of life
Enrollment 408
Condition
Intervention

Intervention type: Procedure

Intervention name: Baby Massage

Description: Structured massage of the baby

Arm group label: Interventional Arm- Baby Massage

Eligibility

Criteria:

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.

Gender: All

Minimum age: 37 Weeks

Maximum age: 42 Weeks

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Geraldine Boylan, PhD Principal Investigator INFANT UCC
Location
facility
Cork University Maternity Hospital
Location Countries

Ireland

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University College Cork

Investigator full name: Professor Geraldine Boylan

Investigator title: Professor Geraldine Boylan INFANT Centre Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Interventional Arm- Baby Massage

Arm group type: Experimental

Description: Interventional Arm= Baby Massage

Arm group label: Control Arm- no Baby Massage

Arm group type: No Intervention

Description: Control Arm= no Baby Massage

Acronym BabySMART
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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.

Primary purpose: Basic Science

Masking: Single (Outcomes Assessor)

Masking description: Neurodevelopmental assessors are blinded to interventional arm.

Source: ClinicalTrials.gov