CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Echo scansother
Likely dose
Not stated in record
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Search/NCT05235399
NCT05235399N/ACompleted

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 Trust·observational·Posted Feb 11, 2022·Updated Aug 1, 2023

In Brief

An observational study evaluating Echo scans for Bronchopulmonary Dysplasia and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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. 2\. 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 11, 2022
Enrollment StartJun 1, 2022
Primary CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.4 years ago

Interventions

Echo scansother

Echo heart scan will be performed on the participating preterm infants on the 5th and 9th day of postnatal life.