Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
2019年8月16日 更新者：De Clifford-Faugère Gwenaelle、St. Justine's Hospital
Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development.
Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited.
Thus, we investigated an intervention based on olfactive stimulation with mothers' milk.
The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain.
Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care.
Pain will be measured using a scale of pain adapted for preterm infants.
This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.
研究概览
地位
未知
研究类型
介入性
注册 (预期的)
96
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 8个月 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria for mothers
- 18 years or older,
- speak, understand and write French or English
- express their milk
Exclusion Criteria for mothers
- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)
Inclusion Criteria for preterm
- 29 to 36 weeks of gestation
- APGAR > 6 at 5 minutes
- less than 21 days
Exclusion Criteria for preterm
- intubated, under Continuous Positive Airway Pressure or nasal oxygen,
- surgery in the first day of life
- congenital disease
- intraventricular hemorrhage > grade II
- leukomalacia
- sedation within 48 hours prior to heel prick
- pharmacologic treatment for pain within 12 hours prior to heel prick
- being under phototherapy treatment during the familiarization stage
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Olfactive stimulation intervention with familiarization
Participants will receive the olfactive stimulation intervention with mothers' milk odor during a previous period of nine hours and during heel prick.
Sucrose will be also administered during heel prick.
|
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
For the familiarization stage, infants were familiarized with the odor of their mothers' milk for 9 hours before heel prick.
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实验性的：Olfactive stimulation intervention
Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only.
Sucrose will be also administered during heel prick.
|
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
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其他：Standard care
In the control arm, participants will receive the standard care for pain which is sucrose administration.
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Preterm infants will receive sucrose during heel prick.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain : Premature Infant Pain Profile-Revised
大体时间：Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
|
Scores range from 0 to 21 where a higher score means more pain, a score less than 6 signifies an absence of pain, and a score greater than 12 indicates moderate to severe pain.
The PIPP-R contains four parts: gestational age, state of sleep-awake, physiological parameters, and behavioural parameters.
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Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recovery
大体时间：The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
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The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
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Maternal acceptability of the olfactive stimulation intervention : questionnaire
大体时间：Immediately post-procedure
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After the intervention, mothers will be asked to complete a questionnaire focusing on maternal acceptability of the olfactive stimulation intervention with mothers' milk to manage procedural pain (demographic questions and Likert scale).
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Immediately post-procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Marilyn Aita, PhD、Université de Montréal
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- De Clifford-Faugere G, Lavallee A, Aita M. Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol. Syst Rev. 2017 Oct 17;6(1):203. doi: 10.1186/s13643-017-0589-1.
- De Clifford-Faugère G, Aita M, Héon M, Le May S. Management of procedural pain in preterm infants through olfactive stimulation with mothers' milk: A pilot study. Science of Nursing and Health Practices - Science infirmière et pratiques en santé. 2(1), Article 3, 2019. Available at: https://doi.org/10.31770/2561-7516.1042
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年9月1日
初级完成 (预期的)
2020年12月1日
研究完成 (预期的)
2020年12月1日
研究注册日期
首次提交
2019年8月12日
首先提交符合 QC 标准的
2019年8月16日
首次发布 (实际的)
2019年8月20日
研究记录更新
最后更新发布 (实际的)
2019年8月20日
上次提交的符合 QC 标准的更新
2019年8月16日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.