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Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome

2011年11月23日 更新者:DR. VIKRAM DATTA、Lady Hardinge Medical College

A Randomised Controlled Trial to Evaluate the Role of Repeated Painful Procedures in Preterm Neonates on Short Term Neurobehavioural Outcome

Procedural pain in neonates is recently acknowledged entity and many studies on the use of pharmacological as well as non pharmacological interventions for alleviation of this pain have been done. Of these, sucrose with or without non nutritive sucking has been the most widely studied and accepted form of pain relief. Its analgesic effect is thought to be mediated by endogenous opioid pathways activated by sweet taste (orogustatory effect).

Although, guidelines based on systematic reviews and meta-analysis for pain management recommend the use of sucrose solutions for pain relief during procedures, the use of repeated doses of sucrose with preterm neonates requires further investigation.

Pain may have profound consequences for preterm neonates during a critical time of brain development. Data derived from animal models suggests that repeated painful stimuli may result in structural and functional reorganization of the nervous system and alteration in future pain response. Early pain experience during this critical period in development are thought to have immediate and long term consequences that could influence physiological, behavioral and developmental outcomes. Early repetitive procedural pain related stress in very preterm neonates is associated with poorer neurobehaviour in first 2 years of life.1 This study aims to assess the effect of repeated painful stimuli on short term neurobehaviour of preterm infants and the efficacy of repeated doses of sucrose used for pain relief.

研究概览

地位

完全的

条件

详细说明

DEFINITION OF PAIN - an unpleasant sensory and emotional experience with actual or potential damage or described in terms of such damage (note that the inability to communicate verbally or non verbally does not negate the possibility that an individual is having pain and is in need of appropriate pain relieving treatment)

HISTORICAL BACKGROUND- we as clinicians have emerged from a period of relative neglect of neonatal pain and are now recognizing the immediate and long term impact of pain on the neonatal development as well as the need to alleviate pain effectively. Neonatal pain has been acknowledged and Paediatric societies such as American Academy of Paediatrics and Canadian paediatric society (2000) have adopted specific guidelines on pain relief in neonates .

LONG TERM EFFECTS OF CHRONIC PAIN -Early repeated procedural pain in NICU has been proposed as one of the factors that may contribute to altered development of cognition ,motor function and behaviour in infants and children born preterm.The vulnerability of preterms is well established due to their lower pain threshold ,sensitization from repeated pain and immature systems for maintaining homeostasis .For infants with extremely immature physiological and neurobehavioural systems ,continual adaptation to repeated challenges induces long term alterations in pain sensitivity, might affect generalized stress arousal systems and potentially affect the developing cytotexture of the brain. The physiologic perturbations associated with early prolonged exposure to episodic pain appear to contribute to altering the rapidly developing stress systems .Exposure to painful procedures in early neonatal period affects the long term neurobehavioural outcome.

.

SCALE USED TO ASSESS SHORT TERM NEUROBEHAVIOUR

NAPI (NEUROBEHAVIOURAL ASSESSMENT OF PRETERM INFANT) -The NAPI is appropriate for infants between 32 weeks post conceptional age and term. It assesses the relative maturity of functioning of preterm infants,with higher scores reflecting higher maturity , and can differentiate 2 weeks PCA . The clinical validity and sensitivity of NAPI were established using an index of medical complications based on a 1-5 classification range of degrees of complications21 The items in the motor development cluster include ventral suspension, prone head raising ,the crawling reflex ,forearm recoil ,power of active movements , and vigor of spontaneous movements .The alertness and orientation items include percent of time in an alert state ,duration and quality of alertness , quantitative response to inanimate and animate visual and auditory stimulation and qualitative ratings that express the nature of response.

LACUNAE IN KNOWLEDGE -Preterm infants are more prone to undergo multiple painful procedures due to their prolonged stay in the neonatal intensive care unit and their typical vulnerable clinical profile.It has now been proved that painful procedures lead to long term changes in the pain reactivity and also affect the long term neurobehavioural outcome in these preterm infants.When a medline search was carried out on the subject it did not return any result.Currently there is no study which has tried to explore the short term neurobehavioural outcome in preterm babies >32 weeks - <37 weeks of gestation who undergo multiple painful procedures during their NICU stay.The present study was thus planned to evaluate the role of sucrose analgesia in alleviating the pain caused by the routine NICU procedures over a period of 7 days and to assess the early neurobehavioural outcome in these babies with the help of a well designed double blinded randomized controlled trial.

研究类型

介入性

注册 (实际的)

106

阶段

  • 第三阶段

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。

学习地点

      • Delhi、印度
        • Lady Hardinge Medical College,New Delhi
      • New Delhi、印度、110001
        • Lady Hardinge Medical College

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

1天 至 4周 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. All preterms (more than equal to 32 weeks to less than 37 weeks)
  2. within first 48 hrs of post natal life
  3. Clinically stable from respiratory and hemodynamic point of view
  4. Parental consent

Exclusion Criteria:

  1. neonates requiring ventilatory support
  2. neonates with any neurological impairment(HIE ,seizures)
  3. receiving opiates or born to mothers receiving opiates
  4. newborns who have received muscle relaxants ,sedatives or analgesics
  5. grade 3 or 4 IVH
  6. major congenital anomalies
  7. 5 mins apgar of less than 7
  8. Neonates undergoing any surgery
  9. Birth trauma

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:放映
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Sucrose
The enrolled neonates will be administered a sterile solution of 24 % sucrose orally for a period of 7 days from enrollment The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure.
The enrolled neonates will be administered either a sterile solution of 24 % sucrose or double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
其他名称:
  • 蔗糖
The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
其他名称:
  • Distilled Water
安慰剂比较:Placebo
The enrolled neonates will be administered double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
其他名称:
  • Distilled Water

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
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the NAPI scale.
大体时间:40 weeks of post conceptional age.
Short term neurobehaviour status at enrollment in the study and at 40weeks post conceptional age using the(Neurobehavioural Assessment of Preterm Infant) NAPI scale.
40 weeks of post conceptional age.

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

  • 学习椅:VIKRAM DATTA, MD、Lady Hardinge Medical College

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

2010年7月1日

初级完成 (实际的)

2011年11月1日

研究完成 (实际的)

2011年11月1日

研究注册日期

首次提交

2010年8月27日

首先提交符合 QC 标准的

2010年8月27日

首次发布 (估计)

2010年8月30日

研究记录更新

最后更新发布 (估计)

2011年11月24日

上次提交的符合 QC 标准的更新

2011年11月23日

最后验证

2011年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pain and Neurobehaviour

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.

24% Sucrose的临床试验

3
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