NCT03381027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

December 11, 2017

Last Update Submit

October 27, 2020

Conditions

SleepNeurodevelopmental Disorders

Keywords

Infant SleepBaby MassageNeurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

  • Infant sleep measured by video EEG length of sleep cycles

    Sleep EEG

    assessment carried out in fourth month of life

Secondary Outcomes (1)

  • Neuro-development measured by Griffiths 3 Developmental Assessment

    Assessment carried out at 4 & 18 month of life

Study Arms (2)

Interventional Arm- Baby Massage

EXPERIMENTAL

Interventional Arm= Baby Massage

Procedure: Baby Massage

Control Arm- no Baby Massage

NO INTERVENTION

Control Arm= no Baby Massage

Interventions

Baby MassagePROCEDURE

Structured massage of the baby

Interventional Arm- Baby Massage

Eligibility Criteria

Age37 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Maternity Hospital

Cork, Munster, Ireland

Location

Related Publications (2)

  • O Sullivan MP, Livingstone V, Korotchikova I, Dempsey EM, Murray DM, Boylan GB. Reference centiles for infant sleep parameters from 4 to 16 weeks of age: findings from an Irish cohort. Arch Dis Child. 2023 Jun;108(6):481-485. doi: 10.1136/archdischild-2022-324016. Epub 2023 Mar 21.

    PMID: 36944485DERIVED

  • 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.

    PMID: 34755881DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Geraldine Boylan, PhD

    INFANT UCC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Neurodevelopmental assessors are blinded to interventional arm.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Geraldine Boylan INFANT Centre Director

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 21, 2017

Study Start

June 5, 2017

Primary Completion

December 16, 2019

Study Completion

June 9, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

IE(1)