跳至主要内容
临床试验/NCT05235399
NCT05235399已完成不适用

Exploring Right vEntricular Function Applicability in a Prediction mOdel to Identify pReterm infanTs With Early BronchoPulmonary Dysplasia (REPORT - BPD Study): a Mixed Methods Observational Cohort Feasibility Study

University Hospital Plymouth NHS Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月1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
40
试验地点
1
主要终点
Effect of early Bronchopulmonary dysplasia on the heart right ventricle function.

研究概览

简要总结

Short title REPORT-BPD feasibility study

Design A mixed methods observational cohort feasibility study

Study Setting Neonatal Intensive Care Unit at University Hospitals Plymouth NHS Trust

Aim To explore the feasibility of measuring the right ventricular function of the premature heart to develop a prediction model to identify early BronchoPulmonary Dysplasia in premature infants.

Objectives 1. To assess the feasibility and acceptability of the study procedures e.g., recruitment, echo scans performance, data collection, storage, and analysis.

  1. To identify the sensitive echo parameters in assessing the right ventricle function of the heart to be included in a prediction model to identify early BPD in premature infants.

Study Participants Preterm infants born <32 weeks of gestational age, their parents and healthcare professionals involved in the care of the study's preterm infants.

Sample size 40 preterm infants

Follow-up Each preterm infant will be followed up till they are 36 weeks of post menstrual age (PMA) or until discharge home whichever comes first.

Study Period 18 months

Outcome Measures

  1. Establishing sensitive and feasible echo parameters for detecting right ventricle dysfunction associated with early BPD pulmonary vascular changes.
  2. Suitability of eligibility criteria and sample characteristics.
  3. Fidelity to the study procedures such as recruitment, data collection including echo scans performance at the set time points.
  4. Recruitment, accrual, and retention rates.

详细描述

RATIONALE The current research findings demonstrated a persistently elevated myocardial performance index of the right ventricle (RV) in the first two weeks of postnatal life (WoPL) in preterm infants with incipient BPD. The identification of the early myocardial dysfunction of RV that is associated with early pulmonary vascular disease (PVD) through echo scan examination in the first two WoPL can potentially serve as a marker for detecting preterm infants with an early BPD.

Data from 1,735 infants born between 23-30 weeks of gestational age (GA) showed that the proportion of preterm infants born < 31 weeks needing oxygen decreases from birth to the 7th day of postnatal life (DoPL). This is followed by a steep rise in the number of infants requiring oxygen in the same cohort at the start of the second week of postnatal life (WoPL). The number of preterm infants needing extra oxygen, peaks at the 14th DoPL. These studies indicate that the pathological pulmonary changes start as early as the first 10 DoPL. Furthermore, studies have identified the end of the first week of postnatal life (WoPL) and the beginning of the second WoPL as the time point when early respiratory problems start to surface. According to the vascular theory, the pathological processes affecting the pulmonary vascular bed are already happening before the appearance of the clinical signs associated with early BPD. The proposed study (REPORT-BPD) aims to capture the early burden exerted on the RV by early BPD and its associated pulmonary vascular changes through performing functional echo examinations at two time points, 5th and 9th day of postnatal life (DoPL) and utilising the findings to construct a prediction model.

To our knowledge, no study has used functional echo examinations to assess extra load or strain imposed by early BPD on the RV on the two time points (5th & 9th DoPL) in the first 10 DoPL.

The cardiac muscle of the preterm infant's heart has premature function. The premature heart reduced contractility is secondary to several reasons such as less myofibrils per cross-sectional area together with immature internal organisation. In addition, there is a lower number of β-adrenergic receptors and underdeveloped sympathetic nervous network. Furthermore, the underdeveloped intrinsic myocardial function following preterm birth is the result of abnormal right ventricle performance with remodelling after birth that persists in the first year of life.

Current research supports the vascular theory as the main pathophysiology of BPD i.e., the pathological process of BPD starts in the pulmonary vascular bed prior to the involvement of the parenchyma of the lungs. So, when the early BPD respiratory insufficiency starts to manifest clinically on 7th day of postnatal life, the adverse haemodynamic changes are already ongoing. In addition, the immaturity of the right ventricle (RV) will render the RV more sensitive to the extra burden imposed by the negative haemodynamic effects of early BPD causing worsening of the RV dysfunction.

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
2 Days 至 2 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Effect of early Bronchopulmonary dysplasia on the heart right ventricle function.

时间窗: 20 months

Establishing sensitive and feasible echo parameters for detecting right ventricle dysfunction associated with early BPD pulmonary vascular changes.

次要结局

  • Acquiring relevant data(20 months)
  • Suitability of eligibility criteria and sample characteristics.(20 months)
  • Fidelity to the study procedures.(20 months)

研究者

发起方
University Hospital Plymouth NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验