RecruitingNot ApplicableNCT06087744

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

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


Sponsor

St. Justine's Hospital

Enrollment

124 participants

Start Date

Nov 23, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 24 WeeksMax Age: 34 Weeks

Inclusion Criteria5

  • born between 24 and 33 6/7 weeks GA;
  • ready for SSC
  • 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 Criteria12

  • 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
  • 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

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Interventions

BEHAVIORALNeuroN-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.

BEHAVIORALSSC alone

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


Locations(2)

CHU Sainte-Justine

Montreal, Quebec, Canada

CUSM

Montreal, Quebec, Canada

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NCT06087744


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