Correlation Between Neonatal Cerebral Oxygenation and Later Psychomotor Outcome in Very-low-birth-weight Preterm Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Psychomotor outcome
研究概览
简要总结
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities. Significant anatomical changes in brain structures and abnormal patterns of neuronal myelination and brain connectivity have been associated with preterm birth, with possible long-term effects on cognitive, motor and social skills.
The validation of clinical tools able to predict neurodevelopmental outcomes in the preterm population might help at identifying infants at greatest risk of impairment, who would benefit most from early supportive interventions exploiting brain neuroplasticity.
Near infrared reflected spectroscopy (NIRS) provides a bedside, non-invasive, continuous monitoring of cerebral oxygen saturation (CrSO2), which has been proposed as a predictive marker for later neurodevelopment in neonates undergone cardiac surgery; to date, however, evidence on the correlation between CrSO2 and later neurodevelopment in preterm infants is almost lacking.
This study aims to evaluate whether CrSO2 monitoring, performed before NICU discharge in clinically stable very low birth weight (VLBW) preterm infants, can predict psychomotor outcomes during the first 24 months of corrected age (ca).
详细描述
The improvements in neonatal intensive care occurred over the last decades have led to a substantial increase in the survival rate of preterm infants, especially of extremely low birth weight. Nevertheless, the delicate maturation of central nervous system (CNS) in the extrauterine environment, together with the possible development of prematurity-related clinical complications that could result in brain injury, place this population at high risk for long-term neurodevelopmental disabilities.
Significant anatomical changes in brain structures have been associated with preterm birth; among these, enlarged ventricles and subarachnoid spaces, reduced subcortical white matter and decreased cortical and deep nuclear grey matter are the most common. Additionally, there is increasing evidence of abnormal patterns of neuronal myelination and brain connectivity in preterm infants, with possible concerning long-term effects on language, motor and social skills. As for cognitive abilities, a direct correlation with gestational age (GA) has been previously shown in a large cohort of preterm born children at school age.
In its early phases, the developmental of CNS is characterized by an intrinsic neuroplasticity, according which repeated experiences could influence the arrangement of synaptic connections and neural circuitries, thus resulting in structural and functional changes. By exploiting this feature, an early establishment of supportive interventions¬ might aid to compensate the anatomical and functional constraints connected to preterm birth and to improve preterm infants' neurodevelopment.
The validation of clinical tools able to predict neurodevelopmental outcomes in the preterm population might help at identifying infants at greatest risk of impairment, who would benefit most from early rehabilitative interventions. Near infrared reflected spectroscopy (NIRS) provides a bedside, non-invasive, continuous monitoring of cerebral oxygen saturation (CrSO2) and has been largely adopted to assess neonatal brain oxygenation and perfusion in intensive care settings. Perioperative CrSO2 has been recently proposed as a possible predictor of later neurodevelopmental outcomes in neonates undergone cardiac surgery; data evaluating the correlation between CrSO2 and later neurodevelopment in preterm infants, however, are very scarce and limited to the first days of life; at this time, CrSO2 can be widely influenced by the occurrence of systemic haemodynamic instability and is blind to several clinical complications, known as potential causes of brain damage, that can occur later on during hospital stay and thus are not necessarily directly related to changes in cerebral oxygenation within the first days of life (e.g. necrotizing enterocolitis [NEC], late onset sepsis).
Hence, the aim of this study was to evaluate whether CrSO2 monitoring, performed before NICU discharge in clinically stable very low birth weight (VLBW) preterm infants, can predict psychomotor outcomes during the first 24 months of corrected age (ca).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Days 至 2 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age <32 weeks
- •birth weight <1500 g.
排除标准
- •congenital abnormalities
- •hypoxic-ischemic encephalopathy
- •intraventricular haemorrhage grade 3-4
- •post-haemorrhagic ventricular dilatation
- •periventricular leukomalacia and/or porencephalic cysts
- •general anaesthesia
结局指标
主要结局
Psychomotor outcome
时间窗: 24 months
Psychomotor outcome is assessed by Griffiths Mental Development Scales 0-2 years. Psychomotor outcome is considered normal if DQ\>88.6; lower values characterize psychomotor impairment, which is further defined as mild (-1 to -2 SD, corresponding to 88.6-76.9 DQ), moderate (-2 to -3 SD, corresponding to 76.8- 65.1 DQ) and severe (\<-3 SD, corresponding to 65 DQ).
次要结局
未报告次要终点
研究者
Luigi Corvaglia
Associate Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
