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

October 27, 2020 updated by: Professor Geraldine Boylan, University College Cork

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See study protocol attached.

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Cork, Munster, Ireland
        • Cork University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Arm- Baby Massage
Interventional Arm= Baby Massage
Procedure: Baby Massage
Structured massage of the baby
No Intervention: Control Arm- no Baby Massage
Control Arm= no Baby Massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant sleep measured by video EEG length of sleep cycles
Time Frame: assessment carried out in fourth month of life
Sleep EEG
assessment carried out in fourth month of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuro-development measured by Griffiths 3 Developmental Assessment
Time Frame: Assessment carried out at 4 & 18 month of life
Griffiths 3 Developmental Assessment
Assessment carried out at 4 & 18 month of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Investigators

  • Principal Investigator: Geraldine Boylan, PhD, INFANT UCC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2017

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

June 9, 2020

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB02/17UCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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