SleepBabySMARTNCT03381027
BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
A study testing Baby Massage in people with Sleep and Neurodevelopmental Disorders, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Sleep, Neurodevelopmental Disorders
- What is being tested?
- Baby Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteIreland
- Study dates
- 5 Jun 2017to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born > 37 weeks gestation
- Single births
- Not requiring admission to the Neonatal Unit
- Healthy infants without suspected congenital or metabolic anomalies
Who cannot join
- Infants born < 37 weeks gestation
- Multiple births
- Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
See study protocol attached.
- Conditions
- Sleep, Neurodevelopmental Disorders
- Being tested
- Baby Massage
- Keywords
- Infant Sleep, Baby Massage, Neurodevelopmental Disorders
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby MassageProcedure or surgery
Structured massage of the baby
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm- Baby Massage | Experimental | Interventional Arm= Baby Massage Receives: Procedure: Baby Massage |
| Control Arm- no Baby Massage | No intervention | Control Arm= no Baby Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant sleep measured by video EEG length of sleep cycles
Sleep EEG
Measured: assessment carried out in fourth month of life
Secondary outcomes (1)
Neuro-development measured by Griffiths 3 Developmental Assessment
Griffiths 3 Developmental Assessment
Measured: Assessment carried out at 4 & 18 month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start5 Jun 2017
- Primary completion16 Dec 2019
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Geraldine Boylan, University College Cork
- Investigators
- Geraldine Boylan, PhD, Principal investigator, INFANT UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381027
- Sponsor's protocol ID
- GB02/17UCC
- Acronym
- BabySMART
- Status last verified
- Oct 2020
- First submitted
- 11 Dec 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36944485Ventura 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.
PubMed 34755881
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
- ClinicalTrials.gov ID
- NCT03381027
- Acronym / sponsor ID
- BabySMART / GB02/17UCC
- Conditions
- Sleep, Neurodevelopmental Disorders
- Keywords
- Infant Sleep, Baby Massage, Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm- Baby Massage | Experimental | Procedure: Baby MassageInterventional Arm= Baby Massage |
| Control Arm- no Baby Massage | No intervention | –Control Arm= no Baby Massage |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born > 37 weeks gestation
- Single births
- Not requiring admission to the Neonatal Unit
- Healthy infants without suspected congenital or metabolic anomalies
Key exclusion criteria (3 listed)
- Infants born < 37 weeks gestation
- Multiple births
- Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby MassageStructured massage of the baby | Procedure or surgery | Interventional Arm- Baby Massage |
Primary outcome
Infant sleep measured by video EEG length of sleep cycles
Time frame: assessment carried out in fourth month of life
Sleep EEG
1 secondary outcome
Neuro-development measured by Griffiths 3 Developmental Assessment
Time frame: Assessment carried out at 4 & 18 month of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 36944485O 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.
- Derived from this study: PubMed 34755881Ventura 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine Boylan, PhD principal investigator
INFANT UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Massage in people with Sleep and Neurodevelopmental Disorders, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant sleep measured by video EEG length of sleep cycles (time frame: assessment carried out in fourth month of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381027, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.