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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое NeuroN-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.
• Поведенческое SSC alone
  Skin-to-skin contact (SSC) lasting 2 hours

Первичные конечные точки

• Neurodevelopment [Срок оценки: 36 weeks gestational age (GA)]

Вторичные конечные точки (7)

• Neurodevelopment [Срок оценки: 4 months and 18 months]
• Neurodevelopment [Срок оценки: 4 months and 18 months]
• Parental Stress [Срок оценки: Baseline before randomization and every week after until 36 weeks GA]
• Parental Anxiety [Срок оценки: Baseline before randomization and every week after until 36 weeks GA]
• Parental sensitivity [Срок оценки: 4 months ans 18 months]
• Milk production [Срок оценки: Every day in mL until study completion at infants' 36 weeks gestational age.]
• Milk consumption [Срок оценки: Total in mL until study completion at infants' 36 weeks gestational age.]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 2 центра

• CHU Sainte-Justine — Montreal
• CUSM — Montreal

Идентификаторы

NCT: NCT06087744 · MP-21-2023-5375

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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