Neurodevelopmental DisordersNCT06087744
NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
A study testing NeuroN-QI and SSC alone in people with Neurodevelopmental Disorders, run by St. Justine's Hospital at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- NeuroN-QI and SSC alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Nov 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born between 24 and 33 6/7 weeks GA;
- ready for SSC
- 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
- For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.
Who cannot join
- 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
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- 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
- mothers had a breast surgery that could influence their breast milk production
- do not speak, read or write in French or in English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kate St-Arneault, Ph.D (cand.) contact
Canada2 sites, 2 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Marilyn Aita, 514-343-6111 ext. 51473, marilyn.aita@umontreal.ca
- Not yet recruiting
CUSM
Montreal, Quebec, H4A 3J1
Jessica Duby, jessica.duby@mcgill.ca
About this study
Official title: Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical 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.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- NeuroN-QI, SSC alone
- Keywords
- NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
SSC aloneBehavioural
Skin-to-skin contact (SSC) lasting 2 hours
| Study group | Role | What they receive |
|---|---|---|
| NeuroN-QI | Experimental | Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be 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. Receives: Behavioral: NeuroN-QI |
| SSC alone | Active comparator | Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation. Receives: Behavioral: SSC alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopment
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
Measured: 36 weeks gestational age (GA)
Secondary outcomes (7)
Neurodevelopment
Cerebral discontinuity activity vs. activity with EEG
Measured: 4 months and 18 months
Neurodevelopment
Bayley-IIII (Questionnaire)
Measured: 4 months and 18 months
Parental Stress
Questionnaire - Parental Stress Scale - Neonatal Intensive Care Unit (NICU) (PSS:NICU) - 25 items with a 5-point Likert-type. Minimum value: 25, maximum value: 100. A higher score indicates higher parental stress.
Measured: Baseline before randomization and every week after until 36 weeks GA
Parental Anxiety
Questionnaire - State-Trait Anxiety Inventory (STAI) - 20 items with a 4-point Likert-type scale. Minimum value: 20; maximum value: 80. A higher score indicates higher anxiety.
Measured: Baseline before randomization and every week after until 36 weeks GA
Parental sensitivity
Recording through videos and coding with Welch Emotional Connection Screen (WECS) - 4 dimensions: mutual attraction, facial communication, vocal communication and sensitivity/reciprocity are coded on a 9-point scale from 1 to 3. Minimum value 4; maximum value 12. Higher scores indicate a better mother-child emotional connection.
Measured: 4 months ans 18 months
Milk production
Through diary
Measured: Every day in mL until study completion at infants' 36 weeks gestational age.
Milk consumption
Through charting
Measured: Total in mL until study completion at infants' 36 weeks gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start23 Nov 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn Aita, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087744
- Sponsor's protocol ID
- MP-21-2023-5375
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT06087744
- Acronym / sponsor ID
- MP-21-2023-5375
- Conditions
- Neurodevelopmental Disorders
- Keywords
- NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Oct 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroN-QI | Experimental | Behavioral: NeuroN-QIRandomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be 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. |
| SSC alone | Active comparator | Behavioral: SSC aloneRandomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation. |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- born between 24 and 33 6/7 weeks GA;
- ready for SSC
- 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
- For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.
Key exclusion criteria (12 listed)
- 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
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-QISkin-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 | NeuroN-QI |
| SSC aloneSkin-to-skin contact (SSC) lasting 2 hours | Behavioural | SSC alone |
Primary outcome
Neurodevelopment
Time frame: 36 weeks gestational age (GA)
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
7 secondary outcomes
Neurodevelopment
Time frame: 4 months and 18 months
Neurodevelopment
Time frame: 4 months and 18 months
Parental Stress
Time frame: Baseline before randomization and every week after until 36 weeks GA
Parental Anxiety
Time frame: Baseline before randomization and every week after until 36 weeks GA
Parental sensitivity
Time frame: 4 months ans 18 months
Milk production
Time frame: Every day in mL until study completion at infants' 36 weeks gestational age.
Milk consumption
Time frame: Total in mL until study completion at infants' 36 weeks gestational age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
Kate St-Arneault, Ph.D (cand.) contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroN-QI and SSC alone in people with Neurodevelopmental Disorders, run by St. Justine's Hospital at 2 sites 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyn Aita, Ph.D. (514-343-6111 ext. 51473, marilyn.aita@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopment (time frame: 36 weeks gestational age (GA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.