Health TrialsbyHealthPanel

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

ConditionNeurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-34
SponsorSt. Justine's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: NeuroN-QIExperimental treatment 1 intervention
Group B: SSC aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neurodevelopment

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

Time frame
36 weeks gestational age (GA)

Secondary outcomes

1

Neurodevelopment

Cerebral discontinuity activity vs. activity with EEG

Time frame
4 months and 18 months
2

Neurodevelopment

Bayley-IIII (Questionnaire)

Time frame
4 months and 18 months
3

Parental Stress

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.

Time frame
Baseline before randomization and every week after until 36 weeks GA
4

Parental Anxiety

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Justine's Hospital

Lead sponsor

Source ClinicalTrials.gov
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