NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

Neurodevelopmental Disorders Clinical Trial

Official title:

Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087744
• Other study ID #: MP-21-2023-5375
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: St. Justine's Hospital
• Contact: Marilyn Aita, Ph.D.
• Phone: 514-343-6111
• Email: marilyn.aita[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory stimulation with breast milk in the incubator/bed both combined with appropriate light and noise levels to promote neurodevelopment preterm infants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 34 Weeks

Eligibility

Inclusion Criteria for preterm infants:

• born between 24 and 33 6/7 weeks GA;
• ready for SSC

Inclusion criteria for mothers and fathers:

• agree to do at least one SSC session/week combined with 10 min of auditory stimulation until 36 weeks of GA of their preterm infant;
• mothers express breast milk for their preterm infants For twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.

Exclusion criteria for preterm infants:

• congenital anomalies or genetic disorders
• intraventricular hemorrhage > grade II
• are small for GA defined as birth weight <10th percentile
• on postnatal day 19 (maximum days targeted for study start)
• are still receiving analgesics, sedatives, paralyzing agents
• are under mechanical ventilation

Exclusion criteria mothers and fathers:

• are aged <18 years;
• have a physical condition that does not allow the SSC
• abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions
• feed their preterm infant exclusively with commercial infant formula
• mothers had a breast surgery that could influence their breast milk production
• do not speak, read or write in French or in English

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

Behavioral:
• NeuroN-QI
Skin-to-skin contact (SSC) lasting 2 hours with an auditory sensory stimulation followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.
• SSC alone
Skin-to-skin contact (SSC) lasting 2 hours

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	CUSM	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
Primary	Neurodevelopment	Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))	36 weeks gestational age (GA)
Secondary	Neurodevelopment	Cerebral discontinuity activity vs. activity with EEG	4 months and 18 months
Secondary	Neurodevelopment	Bayley-IIII (Questionnaire)	4 months and 18 months
Secondary	Parental Stress	Questionnaire - Parental Stress Scale - Neonatal Intensive Care Unit (NICU) (PSS:NICU) - 25 items with a 5-point Likert-type. Minimum value: 25, maximum value: 100. A higher score indicates higher parental stress.	Baseline before randomization and every week after until 36 weeks GA
Secondary	Parental Anxiety	Questionnaire - State-Trait Anxiety Inventory (STAI) - 20 items with a 4-point Likert-type scale. Minimum value: 20; maximum value: 80. A higher score indicates higher anxiety.	Baseline before randomization and every week after until 36 weeks GA
Secondary	Parental sensitivity	Recording through videos and coding with Welch Emotional Connection Screen (WECS) - 4 dimensions: mutual attraction, facial communication, vocal communication and sensitivity/reciprocity are coded on a 9-point scale from 1 to 3. Minimum value 4; maximum value 12. Higher scores indicate a better mother-child emotional connection.	4 months ans 18 months
Secondary	Milk production	Through diary	Every day in mL until study completion at infants' 36 weeks gestational age.
Secondary	Milk consumption	Through charting	Total in mL until study completion at infants' 36 weeks gestational age.