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

April 17, 2024 updated by: Marilyn Aita, St. Justine's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
      • Montréal, Quebec, Canada, H4A 3J1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroN-QI
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.
Behavioral: 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.
Active Comparator: SSC alone
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.
Behavioral: SSC alone
Skin-to-skin contact (SSC) lasting 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
36 weeks gestational age (GA)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopment
Time Frame: 4 months and 18 months
Cerebral discontinuity activity vs. activity with EEG
4 months and 18 months
Neurodevelopment
Time Frame: 4 months and 18 months
Bayley-IIII (Questionnaire)
4 months and 18 months
Parental Stress
Time Frame: Baseline before randomization and every week after until 36 weeks GA
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
Time Frame: Baseline before randomization and every week after until 36 weeks GA
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
Time Frame: 4 months ans 18 months
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
Time Frame: Every day in mL until study completion at infants' 36 weeks gestational age.
Through diary
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.
Through charting
Total in mL until study completion at infants' 36 weeks gestational age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-21-2023-5375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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