Nurturing and Quiet Intervention: NeuroN-QI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Neurodevelopment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

NeuroN-QI

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

26 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes