Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical score assessment PIPP (Premature Infant Pain Profile)
研究概览
简要总结
Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.
Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neonates fed with their mother breast milk,
- •gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days,
- •postnatal age ≤ 10 days
- •birth weight greater than the 5th percentile according to Olsen curves et al.
- •clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease
- •the two legal representatives must have signed an informed consent.
排除标准
- •neonates for whom no video was recorded during the venipuncture
研究组 & 干预措施
maternal breast milk odor
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused.
干预措施: maternal breast milk odor (Other)
no odor
In a second control group, venipuncture was performed to the neonate with an odorless diffusor.
干预措施: no odor (Other)
结局指标
主要结局
clinical score assessment PIPP (Premature Infant Pain Profile)
时间窗: 20 minutes
次要结局
- salivary cortisol level(20 minutes)
- DAN score (Acute Pain of Newborn)(20 minutes)