search
Back to results

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

Primary Purpose

Sleep, Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Baby Massage
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep focused on measuring Infant Sleep, Baby Massage, Neurodevelopmental Disorders

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cork University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional Arm- Baby Massage

Control Arm- no Baby Massage

Arm Description

Interventional Arm= Baby Massage

Control Arm= no Baby Massage

Outcomes

Primary Outcome Measures

Infant sleep measured by video EEG length of sleep cycles
Sleep EEG

Secondary Outcome Measures

Neuro-development measured by Griffiths 3 Developmental Assessment
Griffiths 3 Developmental Assessment

Full Information

First Posted
December 11, 2017
Last Updated
October 27, 2020
Sponsor
University College Cork
search

1. Study Identification

Unique Protocol Identification Number
NCT03381027
Brief Title
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Acronym
BabySMART
Official Title
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Neurodevelopmental Disorders
Keywords
Infant Sleep, Baby Massage, Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Neurodevelopmental assessors are blinded to interventional arm.
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Arm- Baby Massage
Arm Type
Experimental
Arm Description
Interventional Arm= Baby Massage
Arm Title
Control Arm- no Baby Massage
Arm Type
No Intervention
Arm Description
Control Arm= no Baby Massage
Intervention Type
Procedure
Intervention Name(s)
Baby Massage
Intervention Description
Structured massage of the baby
Primary Outcome Measure Information:
Title
Infant sleep measured by video EEG length of sleep cycles
Description
Sleep EEG
Time Frame
assessment carried out in fourth month of life
Secondary Outcome Measure Information:
Title
Neuro-development measured by Griffiths 3 Developmental Assessment
Description
Griffiths 3 Developmental Assessment
Time Frame
Assessment carried out at 4 & 18 month of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geraldine Boylan, PhD
Organizational Affiliation
INFANT UCC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Maternity Hospital
City
Cork
State/Province
Munster
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34755881
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs