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

St. Justine's Hospital

Status: Enrolling

Conditions: Neurodevelopmental Disorders

Treatments: Behavioral: SSC alone; Behavioral: NeuroN-QI

Study type: Interventional

Funder types: Other

Identifiers

NCT06087744

MP-21-2023-5375

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 24 to 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

NeuroN-QI

Experimental group

Description:

Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be 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.

Treatment:

Behavioral: NeuroN-QI

SSC alone

Active Comparator group

Description:

Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation.

Treatment:

Behavioral: SSC alone