NCT06087744招募中不适用
Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial
St. Justine's Hospital4 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年11月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Neurodevelopment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Neurodevelopment
时间窗: 36 weeks gestational age (GA)
Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))
次要结局
- Milk consumption(Total in mL until study completion at infants' 36 weeks gestational age.)
- Parental Anxiety(Baseline before randomization and every week after until 36 weeks GA)
- Parental Stress(Baseline before randomization and every week after until 36 weeks GA)
- Parental sensitivity(4 months ans 18 months)
- Milk production(Every day in mL until study completion at infants' 36 weeks gestational age.)
- Neurodevelopment(4 months and 18 months)
研究者
Marilyn Aita
Researcher
St. Justine's Hospital
研究点 (4)
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