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NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

Primary Purpose

Neurodevelopmental Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NeuroN-QI
SSC alone
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurodevelopmental Disorders focused on measuring NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control

Eligibility Criteria

24 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for preterm infants: born between 24 and 33 6/7 weeks GA; ready for SSC Inclusion criteria 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 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: 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 mothers had a breast surgery that could influence their breast milk production do not speak, read or write in French or in English

Sites / Locations

  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NeuroN-QI

SSC alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Neurodevelopment
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))

Secondary Outcome Measures

Neurodevelopment
Cerebral discontinuity activity vs. activity with EEG
Neurodevelopment
Bayley-IIII (Questionnaire)
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.
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.
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.
Milk production
Through diary
Milk consumption
Through charting

Full Information

First Posted
September 13, 2023
Last Updated
October 11, 2023
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06087744
Brief Title
NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
Official Title
Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 noise levels to promote neurodevelopment preterm infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders
Keywords
NICU, skin to skin contact, neurodevelopment, preterm infants, positive stimulation, environmental control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NeuroN-QI
Arm Type
Experimental
Arm Description
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.
Arm Title
SSC alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NeuroN-QI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SSC alone
Intervention Description
Skin-to-skin contact (SSC) lasting 2 hours
Primary Outcome Measure Information:
Title
Neurodevelopment
Description
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
Time Frame
36 weeks gestational age (GA)
Secondary Outcome Measure Information:
Title
Neurodevelopment
Description
Cerebral discontinuity activity vs. activity with EEG
Time Frame
4 months and 18 months
Title
Neurodevelopment
Description
Bayley-IIII (Questionnaire)
Time Frame
4 months and 18 months
Title
Parental Stress
Description
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.
Time Frame
Baseline before randomization and every week after until 36 weeks GA
Title
Parental Anxiety
Description
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.
Time Frame
Baseline before randomization and every week after until 36 weeks GA
Title
Parental sensitivity
Description
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.
Time Frame
4 months ans 18 months
Title
Milk production
Description
Through diary
Time Frame
Every day in mL until study completion at infants' 36 weeks gestational age.
Title
Milk consumption
Description
Through charting
Time Frame
Total in mL until study completion at infants' 36 weeks gestational age.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for preterm infants: born between 24 and 33 6/7 weeks GA; ready for SSC Inclusion criteria 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 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: 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 mothers had a breast surgery that could influence their breast milk production do not speak, read or write in French or in English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyn Aita, Ph.D.
Phone
514-343-6111
Ext
51473
Email
marilyn.aita@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kate St-Arneault, Ph.D (cand.)
Email
kate.st-arneault.hsj@ssss.gouv.qc.ca
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

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