NL-OMON40085已完成不适用
ong Term Consequences of Neonatal Pain: a neuropsychological and fMRI study - Long Term Consequences of Neonatal Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •Children and adolescents with a medical history of significant neonatal pain experience and treatment with morphine. These children and adolescents are divided in five different groups. ;1. Prematurely born children and term children with the need of ventilation who participated in a randomized, blind, placebo-controlled trial (METC 187629/1999/231).
- •The inclusion criteria are:
- •Age form 8 years on
- •Participation in the original RCT
- •Morphine administration as neonate during mechanical ventilation
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening;2. children who were admitted to the PICU of the Erasmus MC-Sophia in Rotterdam and participated in a RCT comparing the efficacy of continuous intravenous morphine infusion with intermittent infusion after surgery (in their first month of life).
- •The inclusion criteria are:
- •Age form 8 years on
- •Participation in the original RCT
- •Morphine administration as neonate after major abdominal or thoracic surgery within the first month of life
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening;3. children who received neonatal ECMO therapy in their medical history at the PICU of the Erasmus MC-Sophia in Rotterdam.
- •The inclusion criteria are:
- •Age form 8 years on
- •ECMO treatment as neonate
- •Participation in the multidisciplinary follow up program at the Erasmus MC-Sophia
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening;4. children who received Methadone during infancy.
- •The inclusion criteria are:
- •Age form 8 years on
- •Methadone administration in the first year of life during weaning from opioids
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening;5. children with a medical history of major surgery in their first year of life because of a Tierfell-naevus.
- •The inclusion criteria are:
- •Age form 8 years on
- •Dermabrasion in the first 4 months of life due to a Tierfell-naevus
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening;Controls were matched for gender and age and had never had a PICU admission or a history of analgesic- and/or sedative use.
- •The inclusion criteria for the controls are:
- •same sex as the case
- •within an age range of 1 year (but not younger than 8 years old)
- •without a history of neonatal pain and Intensive Care admission
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening;Prenatally exposed to hard drugs
- •The final group we want to include in this study are children who were exposed to opioids and opioid related substances (methadone and heroine) in utero. These foetuses received high amounts of opioids during the important period of brain development.
- •82 children born between 1993 and 2005 are eligible for this follow up study.
- •No publications concerning long-term effects of prenatal opioid exposure on brain development or pain processing are available. ;The inclusion criteria are:
- •Age from 8 years onwards
- •Prenatal exposure to opioids and opioid related substances (heroine, methadone)
- •Informed consent from the parents/caregivers
- •Successfully passed the contra-indication screening
排除标准
- •- Any ferrous metal inside the body (such as a pacemaker)
- •- Claustrophobia
- •- Significant motoric or sensory disabilities (such as blindness or deafness)
- •- History of head injury with loss of consciousness
- •- Diagnosed neurologic disorder
- •- Permanent braces
研究者
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