NeurodevelopmentNeuroN-QINCT04593095
Nurturing and Quiet Intervention: NeuroN-QI
A study testing NeuroN-QI in people with Neurodevelopment, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. Read more about this study
- Who is it for?
- Ages 26 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopment
- What is being tested?
- NeuroN-QI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 1 Jun 2024
- 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 26 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants:
- born between 26 and 316/7 WGA.
- Mothers
- agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
- express breast milk for their infant;
- speak, read, or write French or English.
Show all 9Show fewer
- Nurses:
- have at least 6 months of work experience in a NICU;
- speak and read French or English.
Who cannot join
- Infants:
- have birth defects or genetic disorders;
- have an intraventricular hemorrhage > grade II;
- receive nasal respiratory support;
- have been transferred from another hospital.
- Mothers:
Show all 11Show fewer
- are <18 years of age;
- had a multiparous birth;
- have a physical condition that does not allow SSC;
- abuse substances or alcohol;
- do not intend to breastfeed or give breastmilk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial
The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.
- Conditions
- Neurodevelopment
- Being tested
- NeuroN-QI
- Keywords
- developmental care, preterm infants, mothers, pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroN-QIOther
SSC session lasting 2-hr during the day 4 times/wk including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise followed by a 1-hr quiet period where infants will rest in their incubator/crib with olfactory stimulation and where the control of light and noise levels will be continued.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Each SSC session will last 2-hr during the day including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise. The 2-hr SSC will be followed by a 1-hr quiet period where infants will rest in their incubator/crib with a pad immersed with their mother breast milk for olfactory stimulation and where the control of light and noise levels will be continued. The NeuroN-QI will be done 4 times/wk for each dyad. Receives: Other: NeuroN-QI |
| Control | No intervention | Mothers-infant dyads will do 4 SSC/wk. During these sessions, no attempt will be made by the RA to control the light and noise levels nor to encourage auditory stimulation. The SSC periods will not be followed by a quiet period nor olfactory stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)
questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant
Measured: 1 year
Secondary outcomes (7)
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)
Observation scale by videos
Measured: 1 year
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)
Observation by videos
Measured: 1 year
Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU
Measured: 1 year
Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y
Measured: 1 year
Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire
Questionnaire completed by nurses - each question treated separately from strongly disagree to totally strongly agree (no total score)
Measured: 1 year
Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire
questionnaire completed by nurses - each question treated separately from totally acceptable to totally unacceptable (no total score)
Measured: 1 year
Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire
questionnaire completed by nurses - each question treated separately from totally feasible to totally unfeasible (no total score)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jun 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeurodevelopmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn Aita, Université de Montréal
- Investigators
- Marilyn Aita, PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593095
- Sponsor's protocol ID
- MP-21-2020-2587 (MP)
- Acronym
- NeuroN-QI
- Status last verified
- Nov 2023
- First submitted
- 25 Aug 2020
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aita M, Heon M, Lavallee A, De Clifford Faugere G, Altit G, Le May S, Dorval V, Lippe S, Larone Juneau A, Remmer E, Rennick JE. Nurturing and quiet intervention (NeuroN-QI) on preterm infants' neurodevelopment and maternal stress and anxiety: A pilot randomized clinical trial protocol. J Adv Nurs. 2021 Jul;77(7):3192-3203. doi: 10.1111/jan.14819. Epub 2021 Mar 14.
PubMed 33719093
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04593095
- Acronym / sponsor ID
- NeuroN-QI / MP-21-2020-2587 (MP)
- Conditions
- Neurodevelopment
- Keywords
- developmental care, preterm infants, mothers, pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Oct 2020 (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.
The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: NeuroN-QIEach SSC session will last 2-hr during the day including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise. The 2-hr SSC will be followed by a 1-hr quiet period where infants will rest in their incubator/crib with a pad immersed with their mother breast milk for olfactory stimulation and where the control of light and noise levels will be continued. The NeuroN-QI will be done 4 times/wk for each dyad. |
| Control | No intervention | –Mothers-infant dyads will do 4 SSC/wk. During these sessions, no attempt will be made by the RA to control the light and noise levels nor to encourage auditory stimulation. The SSC periods will not be followed by a quiet period nor olfactory stimulation. |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- born between 26 and 316/7 WGA.
- Mothers
- agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
- express breast milk for their infant;
- speak, read, or write French or English.
Key exclusion criteria (11 listed)
- have birth defects or genetic disorders;
- have an intraventricular hemorrhage > grade II;
- receive nasal respiratory support;
- have been transferred from another hospital.
- are <18 years of age;
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 |
|---|---|---|
| NeuroN-QISSC session lasting 2-hr during the day 4 times/wk including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise followed by a 1-hr quiet period where infants will rest in their incubator/crib with olfactory stimulation and where the control of light and noise levels will be continued. | Other | Experimental |
Primary outcome
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)
Time frame: 1 year
questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant
7 secondary outcomes
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)
Time frame: 1 year
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)
Time frame: 1 year
Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU
Time frame: 1 year
Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y
Time frame: 1 year
Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire
Time frame: 1 year
Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire
Time frame: 1 year
Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire
Time frame: 1 year
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 20 Mar 2025.
- Derived from this study: PubMed 33719093Aita M, Heon M, Lavallee A, De Clifford Faugere G, Altit G, Le May S, Dorval V, Lippe S, Larone Juneau A, Remmer E, Rennick JE. Nurturing and quiet intervention (NeuroN-QI) on preterm infants' neurodevelopment and maternal stress and anxiety: A pilot randomized clinical trial protocol. J Adv Nurs. 2021 Jul;77(7):3192-3203. doi: 10.1111/jan.14819. Epub 2021 Mar 14.
- Individual participant dataSharing planned: No
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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.
Marilyn Aita, PhD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroN-QI in people with Neurodevelopment, run by St. Justine's Hospital at 1 site in Canada.
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 9 inclusion and 11 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 20 Mar 2025. 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 Canada. 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?
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA) (time frame: 1 year). 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 NCT04593095, which also lists 1 linked publication.
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 20 Mar 2025.