Recruiting

NeuroN-QI

Sponsor:

St. Justine's Hospital

Code:

NCT06087744

Conditions

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NeuroN-QI

SSC alone

Study Details

Brief 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.

Conditions

Neurodevelopmental Disorders

Study ID

NCT06087744

Start date

Nov 23, 2023

Status verified date

Apr, 2024

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: NeuroN-QI

Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be 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.

active comparator: SSC alone

Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation.

Interventions

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

Primary outcome measure

  • Neurodevelopment [ Time Frame: 36 weeks gestational age (GA) ]

Central Contacts and Locations

Central contacts

Marilyn Aita, Ph.D.

514-343-6111marilyn.aita@umontreal.ca

Kate St-Arneault, Ph.D (cand.)

kate.st-arneault.hsj@ssss.gouv.qc.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Marilyn Aita

514-343-6111marilyn.aita@umontreal.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Apr 19, 2024

Last verified

Apr, 2024

Keywords

  • NICU
  • skin to skin contact
  • neurodevelopment
  • preterm infants
  • positive stimulation
  • environmental control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2024-04-19.