Nurturing and Quiet Intervention: NeuroN-QI

Neurodevelopment Clinical Trial

— NeuroN-QI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593095
• Other study ID #: MP-21-2020-2587 (MP)
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2022
• Source: St. Justine's Hospital
• Contact: Marilyn Aita, PhD
• Phone: 5143436111
• Email: marilyn.aita[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Neurodevelopment

Intervention

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.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)	Observation scale by videos	1 year
Secondary	Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)	Observation by videos	1 year
Secondary	Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU		1 year
Secondary	Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y		1 year
Secondary	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
Secondary	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
Secondary	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