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Completed

NCT Number: NCT03381027

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

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.

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Key information

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cork University Maternity Hospital

Cork, Munster, Ireland

About this study

See study protocol attached.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born > 37 weeks gestation
  • Single births
  • Not requiring admission to the Neonatal Unit
  • Healthy infants without suspected congenital or metabolic anomalies

Exclusion criteria

  • Infants born < 37 weeks gestation
  • Multiple births
  • Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.

Treatment and study plan

Baby massage

Procedure

Structured massage of the baby

Primary outcomes

  1. Infant sleep measured by video EEG length of sleep cycles

    Time frame: assessment carried out in fourth month of life

    Sleep EEG

Secondary outcomes

  1. Neuro-development measured by Griffiths 3 Developmental Assessment

    Time frame: Assessment carried out at 4 & 18 month of life

    Griffiths 3 Developmental Assessment

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Acronym: BabySMART

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 21, 2017
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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