Comparing NeuroN-QI with SSC alone for neurodevelopmental disorders
Official title: NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
- 2 groups
- 2 sites in Montreal
- Recruiting
Interventions
- Behavioural therapy
NeuroN-QI
Skin-to-skin contact (SSC) lasting 2 hours with an auditory sensory stimulation followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.
- Behavioural therapy
SSC alone
Skin-to-skin contact (SSC) lasting 2 hours
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec
- Not yet recruiting
CUSM
Montreal, Quebec
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +born between 24 and 33 6/7 weeks GA;
- +for preterm infants:
- +ready for SSC
- +Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for mothers and fathers:
- +agree to do at least one SSC session/week combined with 10 min of auditory stimulation until 36 weeks of GA of their preterm infant;
- +mothers express breast milk for their preterm infants
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for preterm infants:
- +congenital anomalies or genetic disorders
- +intraventricular hemorrhage \> grade II
- +are small for GA defined as birth weight \<10th percentile
- +on postnatal day 19 (maximum days targeted for study start)
- +are still receiving analgesics, sedatives, paralyzing agents
- +are under mechanical ventilation
- +Exclusion criteria mothers and fathers:
- +are aged \<18 years;
- +have a physical condition that does not allow the SSC
- +abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions
- +feed their preterm infant exclusively with commercial infant formula
- +do not speak, read or write in French or in English
- +For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.
- +mothers had a breast surgery that could influence their breast milk production
Exclusion
- −for preterm infants:
- −congenital anomalies or genetic disorders
- −intraventricular hemorrhage \> grade II
- −are small for GA defined as birth weight \<10th percentile
- −on postnatal day 19 (maximum days targeted for study start)
- −are still receiving analgesics, sedatives, paralyzing agents
- −are under mechanical ventilation
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → mothers and fathers:
- −are aged \<18 years;
- −have a physical condition that does not allow the SSC
- −abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions
- −feed their preterm infant exclusively with commercial infant formula
- −do not speak, read or write in French or in English
- −mothers had a breast surgery that could influence their breast milk production
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives NeuroN-QI.
Registry label: A: NeuroN-QI
Group B, the comparison group, receives SSC alone.
Registry label: B: SSC alone
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 24 weeks to 34 weeks.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 124 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: 36 weeks gestational age (GA).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Neurodevelopment — measured over 36 weeks gestational age (GA).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06087744 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About NeuroN-QIBehavioural
Skin-to-skin contact (SSC) lasting 2 hours with an auditory sensory stimulation followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About SSC aloneBehavioural
Skin-to-skin contact (SSC) lasting 2 hours
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 24 weeks to 34 weeks.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 24 weeks to 34 weeks.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 36 weeks gestational age (GA).
The study as a whole is currently expected to finish around 2027-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 124 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory stimulation with breast milk in the incubator/bed both combined with appropriate light and noise levels to promote neurodevelopment preterm infants.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.