Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants Either In Kangaroo Position or in Incubator: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Weight gain after randomization up to 5 days
研究概览
简要总结
Kangaroo position (KP), the essential component of the Kangaroo Mother Care (KMC) method, has been increasingly implemented, given the benefits of early skin-to-skin contact on the cerebral maturation of preterm infants. In addition it allows for parents to bond with their infants and humanize the care of fragile infants in neonatal units. Evidence on kinesthetic stimulation (KS) is scarce and currently there is no available evidence on KS during the KP. KS is associated with massage in this paper
详细描述
The objective is to study the impact of standardized KS delivered either in KP (KSKP) or in an incubator (KSI) on the early growth of very preterm infants.
Patients and methods: Sixty six newborns ≤32 weeks of gestational age at birth received KS delivered 3 times/day during KP or in an incubator. They were randomized when the infants were considered eligibleto initiate KMC which was part of the routine care for all newborns in the Neonatal Care Unit (NCU). The primary outcome were the weight gain (g/kg/day) between randomization, 5, and 15 days after the start of the intervention and weight at 40 weeks of gestational age (term). The secondary outcomes were the same measures according to the chronological age (days of life) of the infant at randomization.
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 (Investigator, Outcomes Assessor)
盲法说明
The nurses who did anthropometrics measures didn't know the interventions assigned to each participant of the study, because the night shift was in charge of taking the data at 7:00 am in the mornings and the interventions were delivered in the morning shifts from 8:00 am until 5:00 pm. No interventions were delivered in the night.
入排标准
- 年龄范围
- 30 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants (GA ≤33 weeks of gestation)
- •Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.
排除标准
- •Infants with congenital anomalies
- •Unstable during the first 15 days of life
研究组 & 干预措施
KS in Kangaroo Position (KSKP)
KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.
干预措施: KS in Kangaroo Position (Behavioral)
KS in incubator (KSI)
The infant is in the incubator, unclothed with diaper.
干预措施: KS in incubator (Behavioral)
结局指标
主要结局
Weight gain after randomization up to 5 days
时间窗: Between randomization and 5 days post randomization
weight gain (g/kg/day)
Weight at 40 weeks of gestational age
时间窗: at 40 weeks of gestational age
Weight in grames
Weight gain after randomization up to 15 days
时间窗: Between randomization and 15 days post randomization
weight gain (g/kg/day)
次要结局
- Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age(after randomization up to 5 days if randomization was made more than 10 days of chronological age)
- Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age(after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age)
- Weight at 40 weeks if randomization was made before 5 days of chronological age(at 40 weeks of gestational age if randomization was made before 5 days of chronological age)
- Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age(at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age)
- Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age(after randomization up to 5 days if randomization was made before 5 days of chronological age)
- Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age(after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age)
- Weight at 40 weeks if randomization was made more than 10 days of chronological age(at 40 weeks of gestational age if randomization was made more than 10 days of chronological age)
- Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age(after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age)
- Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age(after randomization up to 15 days if randomization was made more than 10 days of chronological age)
研究者
Nathalie Charpak
Dr Andrea Aldana
Kangaroo Foundation