Clinical trial NCT04593095: Nurturing and Quiet Intervention: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopment
Keywords: developmental care
preterm infants
mothers
pilot study
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)
timeFrame: 1 year
Secondary outcomes:
measure: Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)
timeFrame: 1 year
measure: Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)
timeFrame: 1 year
measure: Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU
timeFrame: 1 year
measure: Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y
timeFrame: 1 year
measure: Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire
timeFrame: 1 year
measure: Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire
timeFrame: 1 year
measure: Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire
timeFrame: 1 year
Other outcomes:
measure: Confounding variables
timeFrame: 1 year
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Marilyn Aita, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.