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临床试验/NCT04762004
NCT04762004已完成不适用

Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures

University of Geneva, Switzerland2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
pain score

研究概览

简要总结

Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.

详细描述

Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.

The aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.

In the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The pain score was assessed by two blinded independent and trained coders on muted video tracks. Oxytocin analysis were performed by an external Lab, blinded to the conditions.

入排标准

年龄范围
29 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • age >29 weeks gestational age at birth,
  • weight >1000 g
  • stable medical condition (absence of mechanical ventilation, no additional oxygen)

排除标准

  • For infants
  • no specific pathological conditions
  • no genetic abnormalities
  • For mothers
  • history of substance abuse
  • mental health problems

结局指标

主要结局

pain score

时间窗: Immediately after the procedure

The PIPP-R score is a cluster of physiological and behavioural measures. Physiological assessment was calculated on the heart rate and oxygen saturation levels as collected from the patient monitor by the researcher. Inter-rater reliability was assessed by three independent coders: expert coders 1 and 2 performed blinded ratings from offline muted videos and digitally recorded physiological parameters, whereas coder 3 was a trained nurse and performed a direct online rating of the scores. Higher levels of pain scores indicate higher levels of pain

oxytocin levels

时间窗: Immediately after the procedure

Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.

次要结局

未报告次要终点

研究者

发起方
University of Geneva, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuela Filippa

Principal Investigator

University of Geneva, Switzerland

研究点 (2)

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