MedTrace Logo

Right vEntricular Function Prediction mOdel to Identify pReterm infanTs With Early BronchoPulmonary Dysplasia.

NCT05235399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia
  • Right Ventricular Dysfunction
  • In the Perinatal Period

Interventions

OTHER

Echo scans

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

Sponsors & Collaborators

  • University of Plymouth

    collaborator OTHER

  • University Hospital Plymouth NHS Trust

    lead OTHER

Principal Investigators

  • WISAM S MUHSEN, MSc · University of Plymouth

  • Jos Latour, PhD · University of Plymouth

  • Eirik Nestaas, PhD · University of Oslo

  • Joanne Hosking, PhD · University of Plymouth

Eligibility

Min Age
2 Days
Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-05-05
Completion
2023-05-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235399 on ClinicalTrials.gov