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Completed

NCT Number: NCT04593095

Nurturing and Quiet Intervention: NeuroN-QI

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.

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Key information

Conditions

Neurodevelopment

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeuroN-QI

Other

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.

Primary outcomes

  1. Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)

    Time frame: 1 year

    questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant

Secondary outcomes

  1. Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)

    Time frame: 1 year

    Observation scale by videos

  2. Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)

    Time frame: 1 year

    Observation by videos

  3. Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU

    Time frame: 1 year

  4. Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y

    Time frame: 1 year

  5. Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire

    Time frame: 1 year

    Questionnaire completed by nurses - each question treated separately from strongly disagree to totally strongly agree (no total score)

  6. Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire

    Time frame: 1 year

    questionnaire completed by nurses - each question treated separately from totally acceptable to totally unacceptable (no total score)

  7. Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire

    Time frame: 1 year

    questionnaire completed by nurses - each question treated separately from totally feasible to totally unfeasible (no total score)

Other outcomes

  1. Confounding variables

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Acronym: NeuroN-QI

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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