Nurturing and Quiet Intervention: NeuroN-QI (NeuroN-QI)

Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial

The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopment
• Intervention / Treatment: Other: NeuroN-QI

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyn Aita, PhD; Phone Number: 51473 5143436111; Email: marilyn.aita@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine
      • Contact: Marilyn Aita; Phone Number: 51473 514-343-6111; Email: marilyn.aita@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Infants:

- born between 26 and 316/7 WGA.

Mothers

• agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
• express breast milk for their infant;
• speak, read, or write French or English.

Nurses:

• have at least 6 months of work experience in a NICU;
• speak and read French or English.

Exclusion Criteria:

Infants:

• have birth defects or genetic disorders;
• have an intraventricular hemorrhage > grade II;
• receive nasal respiratory support;
• have been transferred from another hospital.

Mothers:

• are <18 years of age;
• had a multiparous birth;
• have a physical condition that does not allow SSC;
• abuse substances or alcohol;
• do not intend to breastfeed or give breastmilk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Each SSC session will last 2-hr during the day including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise. The 2-hr SSC will be followed by a 1-hr quiet period where infants will rest in their incubator/crib with a pad immersed with their mother breast milk for olfactory stimulation and where the control of light and noise levels will be continued. The NeuroN-QI will be done 4 times/wk for each dyad.	Other: NeuroN-QI; SSC session lasting 2-hr during the day 4 times/wk including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise followed by a 1-hr quiet period where infants will rest in their incubator/crib with olfactory stimulation and where the control of light and noise levels will be continued.
NO_INTERVENTION: Control; Mothers-infant dyads will do 4 SSC/wk. During these sessions, no attempt will be made by the RA to control the light and noise levels nor to encourage auditory stimulation. The SSC periods will not be followed by a quiet period nor olfactory stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)	questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)	Observation scale by videos	1 year
Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)	Observation by videos	1 year
Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU		1 year
Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y		1 year
Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire	Questionnaire completed by nurses - each question treated separately from strongly disagree to totally strongly agree (no total score)	1 year
Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire	questionnaire completed by nurses - each question treated separately from totally acceptable to totally unacceptable (no total score)	1 year
Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire	questionnaire completed by nurses - each question treated separately from totally feasible to totally unfeasible (no total score)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confounding variables	birth weight, WGA at birth, postnatal age at the beginning of the intervention, APGAR score, mothers' use of psychological health care resources, other SSC sessions, SNAPPE-II, and light and noise levels with soundmeter and light meter	1 year

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Investigators: Principal Investigator: Marilyn Aita, PhD, St. Justine's Hospital

Publications and helpful links

General Publications

• Aita M, Heon M, Lavallee A, De Clifford Faugere G, Altit G, Le May S, Dorval V, Lippe S, Larone Juneau A, Remmer E, Rennick JE. Nurturing and quiet intervention (NeuroN-QI) on preterm infants' neurodevelopment and maternal stress and anxiety: A pilot randomized clinical trial protocol. J Adv Nurs. 2021 Jul;77(7):3192-3203. doi: 10.1111/jan.14819. Epub 2021 Mar 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): August 30, 2022
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: preterm infants; pilot study; mothers; developmental care
• Other Study ID Numbers: MP-21-2020-2587 (MP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No