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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381027
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Geraldine Boylan, University College Cork

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sleep Neurodevelopmental Disorders Procedure: Baby Massage Not Applicable

Detailed Description:
See study protocol attached.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
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.
Masking: Single (Outcomes Assessor)
Masking Description: Neurodevelopmental assessors are blinded to interventional arm.
Primary Purpose: Basic Science
Official Title: BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : June 9, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Infant sleep measured by video EEG length of sleep cycles [ Time Frame: assessment carried out in fourth month of life ]
    Sleep EEG


Secondary Outcome Measures :
  1. Neuro-development measured by Griffiths 3 Developmental Assessment [ Time Frame: Assessment carried out at 4 & 18 month of life ]
    Griffiths 3 Developmental Assessment


Eligibility Criteria
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Ages Eligible for Study:   37 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381027


Locations
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Ireland
Cork University Maternity Hospital
Cork, Munster, Ireland
Sponsors and Collaborators
University College Cork
Investigators
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Principal Investigator: Geraldine Boylan, PhD INFANT UCC
  Study Documents (Full-Text)

Documents provided by Professor Geraldine Boylan, University College Cork:
Study Protocol and Statistical Analysis Plan  [PDF] July 20, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Geraldine Boylan, Professor Geraldine Boylan INFANT Centre Director, University College Cork
ClinicalTrials.gov Identifier: NCT03381027    
Other Study ID Numbers: GB02/17UCC
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Geraldine Boylan, University College Cork:
Infant Sleep
Baby Massage
Neurodevelopmental Disorders
Additional relevant MeSH terms:
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Neurodevelopmental Disorders
Mental Disorders