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临床试验/NCT05853991
NCT05853991尚未招募不适用

Effects of Affective Touch, Therapeutic Touch (OMT), and Static/Nonspecific Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

Come Collaboration1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
brain changes

研究概览

简要总结

Improving the quality of life of preterm children by 2035 is the top priority of worldwide health organisations, including the WHO. Every year, 15 million preterm infants, particularly those under 32 weeks of age, are at significant risk of neurocognitive impairments with adverse health consequences (disability, developmental delay, disease), exacerbated by the lack of post-hospital care for newborns.

Intervening on the health of the preterm newborn through certain types of "touch" from its first days of life to activate its cutaneous senses permits, in reality, a significant improvement in the clinical state of the infant, hence promoting its growth, development, and social behaviour.

In the neonatal period, during which significant neurological development occurs, tactile interactions and close physical proximity between infants and caregivers have significant short-term effects on the health of premature infants (weight gain, brain and vision development) and medium- to long-term effects on their development and expression of sociability.

The likelihood that a premature newborn may develop attention and autism spectrum disorders, brain, gastrointestinal, and respiratory difficulties, as well as sleep disorders during the preschool years, is so high that clinical and social settings must prioritise care.

Utilizing functional magnetic resonance imaging (fRMI), computerized electroencephalogram (EEG), and metabolomics, the research aims to explore the effects of touch, including physiotherapy and manual therapy (OMT) approaches, on brain activity.

This research intends to examine the impact of touch on premature infants' brain activity (physical biomarker) and metabolic activity (biological biomarker).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
32 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm birth, between 32.0 and 33.6 weeks gestational age (GA);
  • Absence of comorbidities that could affect the stability of vital parameters, and therefore represent a contraindication to the proposed intervention. Comorbities include sepsis, pathologies pertaining to surgery, respiratory or cardiovascular instability, birth from a drug-addicted or HIV-positive mother) or known congenital pathologies;
  • Obtaining informed consent for participation in this research project from parents or legal guardians.

排除标准

  • Preterm infants born before 32.0 weeks of GA and after 34 weeks and with respiratory and neurological pathologies and any additional comorbities.
  • Children whose parents will not read and sign or in case of failure to obtain informed consent will be excluded from the study.

结局指标

主要结局

brain changes

时间窗: 1 hour

pre-post changes in BOLD levels among different brain areas

次要结局

  • Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1(1 hour)
  • Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3(8 days)
  • Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3(8 days)
  • Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5(40 weeks)
  • electroencephalogram (EEG) changes(10 days)
  • Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2(4 days)
  • Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4(12 days)
  • Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1(1 hour)
  • Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2(4 days)
  • Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4(12 days)
  • Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5(40 weeks)
  • Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5(40 weeks)
  • Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1(1 hour)
  • Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2(4 days)
  • Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3(8 days)
  • Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4(12 days)

研究者

发起方
Come Collaboration
申办方类型
Other
责任方
Sponsor

研究点 (1)

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