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Recruiting NCT06087744

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

No phase Interventional Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NeuroN-QI, SSC alone.
Who it may be relevant to
Registry conditions: Neurodevelopmental Disorders. Basic parameters: 24 Weeks — 34 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Behavioral SSC alone
    Skin-to-skin contact (SSC) lasting 2 hours

Primary outcome measures

  • Neurodevelopment [Time frame: 36 weeks gestational age (GA)]
Secondary outcome measures (7)
  • Neurodevelopment [Time frame: 4 months and 18 months]
  • Neurodevelopment [Time frame: 4 months and 18 months]
  • Parental Stress [Time frame: Baseline before randomization and every week after until 36 weeks GA]
  • Parental Anxiety [Time frame: Baseline before randomization and every week after until 36 weeks GA]
  • Parental sensitivity [Time frame: 4 months ans 18 months]
  • Milk production [Time frame: Every day in mL until study completion at infants' 36 weeks gestational age.]
  • Milk consumption [Time frame: Total in mL until study completion at infants' 36 weeks gestational age.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Canada · 2 centers
  • CHU Sainte-Justine — Montreal
  • CUSM — Montreal

Identifiers

NCT: NCT06087744 · MP-21-2023-5375

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗