Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-28 @ 7:39 AM
Study NCT ID:
NCT04593095
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurturing and Quiet Intervention: NeuroN-QI
Sponsor:
St. Justine's Hospital
Organization:
Study Overview
Official Title:
Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeuroN-QI
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: