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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroN-QI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopment | Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB)) | 36 weeks gestational age (GA) |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopment | Cerebral discontinuity activity vs. activity with EEG | 4 months and 18 months |
| Neurodevelopment | Bayley-IIII (Questionnaire) |
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Inclusion Criteria for preterm infants:
Inclusion criteria for mothers and fathers:
For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.
Exclusion criteria for preterm infants:
Exclusion criteria mothers and fathers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marilyn Aita, Ph.D. | Contact | 514-343-6111 | 51473 | marilyn.aita@umontreal.ca |
| Kate St-Arneault, Ph.D (cand.) | Contact | kate.st-arneault.hsj@ssss.gouv.qc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| SSC alone | Behavioral | Skin-to-skin contact (SSC) lasting 2 hours |
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| 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. | 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. | 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. | 4 months ans 18 months |
| Milk production | Through diary | Every day in mL until study completion at infants' 36 weeks gestational age. |
| Milk consumption | Through charting | Total in mL until study completion at infants' 36 weeks gestational age. |
| CUSM | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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