Clinical trial NCT03381027: BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Official title: BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Neurodevelopmental Disorders
Keywords: Infant Sleep
Baby Massage
Neurodevelopmental Disorders
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 408
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Infant sleep measured by video EEG length of sleep cycles
timeFrame: assessment carried out in fourth month of life
Secondary outcomes:
measure: Neuro-development measured by Griffiths 3 Developmental Assessment
timeFrame: Assessment carried out at 4 & 18 month of life
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
state: Munster
Study officials:
affiliation: INFANT UCC
name: Geraldine Boylan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventura S, Mathieson SR, O'Toole JM, Livingstone V, Ryan MA, Boylan GB. Electroencephalographic sleep macrostructure and sleep spindles in early infancy. Sleep. 2022 Jan 11;45(1):zsab262. doi: 10.1093/sleep/zsab262.