Actively Recruiting

Phase Not Applicable
Age: 24Weeks - 34Weeks
All Genders
NCT06087744

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

Led by St. Justine's Hospital · Updated on 2024-04-19

124

Participants Needed

2

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 24Weeks - 34Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born between 24 and 33 6/7 weeks gestational age
  • Infants ready for skin-to-skin contact (SSC)
  • Mothers and fathers agree to perform at least one SSC session per week combined with 10 minutes of auditory stimulation until the infant reaches 36 weeks gestational age
  • Mothers express breast milk for their preterm infants
  • For twin births, fathers are invited to participate so both infants can be included
Not Eligible

You will not qualify if you...

  • Preterm infants with congenital anomalies or genetic disorders
  • Preterm infants with intraventricular hemorrhage greater than grade II
  • Infants who are small for gestational age, defined as birth weight below the 10th percentile
  • Infants beyond postnatal day 19 at study start
  • Infants still receiving analgesics, sedatives, or paralytic agents
  • Infants under mechanical ventilation
  • Mothers and fathers younger than 18 years
  • Parents with physical conditions preventing skin-to-skin contact
  • Parents who abuse illicit substances or alcohol affecting parent-child interactions
  • Infants fed exclusively with commercial infant formula
  • Mothers with breast surgery affecting milk production
  • Parents who do not speak, read, or write in French or English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

2

CUSM

Montreal, Quebec, Canada, H4A 3J1

Not Yet Recruiting

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Research Team

M

Marilyn Aita, Ph.D.

CONTACT

K

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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