Neurodevelopment
Conditions
Keywords
developmental care, preterm infants, mothers, pilot study
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.
Interventions
OTHERNeuroN-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.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 32 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA) | 1 year | questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB) | 1 year | Observation scale by videos |
| Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA) | 1 year | Observation by videos |
| Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU | 1 year | — |
| Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire | 1 year | Questionnaire completed by nurses - each question treated separately from strongly disagree to totally strongly agree (no total score) |
| Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire | 1 year | questionnaire completed by nurses - each question treated separately from totally acceptable to totally unacceptable (no total score) |
| Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire | 1 year | questionnaire completed by nurses - each question treated separately from totally feasible to totally unfeasible (no total score) |
| Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Confounding variables | 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 |
Countries
Canada
Outcome results
None listed