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NCT Number: NCT06087744

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

24 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroN-QI

Behavioral

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

Behavioral

Skin-to-skin contact (SSC) lasting 2 hours

Primary outcomes

  1. Neurodevelopment

    Time frame: 36 weeks gestational age (GA)

    Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))

Secondary outcomes

  1. Neurodevelopment

    Time frame: 4 months and 18 months

    Cerebral discontinuity activity vs. activity with EEG

  2. Neurodevelopment

    Time frame: 4 months and 18 months

    Bayley-IIII (Questionnaire)

  3. Parental Stress

    Time frame: Baseline before randomization and every week after until 36 weeks GA

    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.

  4. Parental Anxiety

    Time frame: Baseline before randomization and every week after until 36 weeks GA

    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.

  5. Parental sensitivity

    Time frame: 4 months ans 18 months

    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.

  6. Milk production

    Time frame: Every day in mL until study completion at infants' 36 weeks gestational age.

    Through diary

  7. Milk consumption

    Time frame: Total in mL until study completion at infants' 36 weeks gestational age.

    Through charting

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

Marilyn Aita, Ph.D.

CONTACT

[email protected]

514-343-6111 ext. 51473

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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