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New treatment option for Neurodevelopmental Disorders
Official title NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
ClinicalTrials.gov ID: NCT06087744
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 34
You may be able to join if
- for preterm infants:
- born between 24 and 33 6/7 weeks GA;
- ready for SSC 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...
You likely can't join if
- 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
See the full eligibility criteria
- for preterm infants:
- born between 24 and 33 6/7 weeks GA;
- ready for SSC 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 weeks to 34 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.