Intervention to support neurodevelopment in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NeuroN-QI evaluates the effects of an intervention designed for preterm infants that includes skin-to-skin contact with parents and auditory stimulation through the parents' voice. The intervention also incorporates calm periods with olfactory stimulation using breast milk, all while maintaining appropriate light and noise levels. This approach aims to enhance neurodevelopmental outcomes in preterm infants by providing positive sensory experiences during their critical early weeks. The study will involve both parents and infants, particularly focusing on those born between 24 and 33 weeks of gestational age.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Sainte-Justine
  Montreal, Quebec, Canada Recruiting
• Cusm
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Study coordinator: Marilyn Aita, Ph.D.
• Email: marilyn.aita@umontreal.ca
• Phone: 514-343-6111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.