MedDataX Logo

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

NCT ID: NCT03381027

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2020-06-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

See study protocol attached.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Neurodevelopmental Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Neurodevelopmental assessors are blinded to interventional arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional Arm- Baby Massage

Interventional Arm= Baby Massage

Group Type EXPERIMENTAL

Baby Massage

Intervention Type PROCEDURE

Structured massage of the baby

Control Arm- no Baby Massage

Control Arm= no Baby Massage

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baby Massage

Structured massage of the baby

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College Cork

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Geraldine Boylan

Professor Geraldine Boylan INFANT Centre Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Geraldine Boylan, PhD

Role: PRINCIPAL_INVESTIGATOR

INFANT UCC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cork University Maternity Hospital

Cork, Munster, Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36944485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34755881 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GB02/17UCC

Identifier Type: -

Identifier Source: org_study_id