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NCT04402645 · ClinicalTrials.gov registry record

Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension

A clinical trial, sponsored by Mount Sinai Hospital, Canada.

Completed
Registry status
350
Enrollment target

NCT04402645 is a clinical trial that has completed, run by Mount Sinai Hospital, Canada. The registered enrollment target is 350 participants.

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The verdict

NCT04402645 has completed, sponsored by Mount Sinai Hospital, Canada.

COMPLETED
Registry status
350 participants
Enrollment target

Study Summary

Chronic pulmonary hypertension (cPHT) is a serious cardiopulmonary disorder that causes low oxygen levels in the blood, difficulty in breathing and ultimately heart failure. Newborn babies born extremely premature frequently suffer from cPHT while receiving treatment in neonatal intensive care units and are more likely to die than those without cPHT. Echocardiography is the investigation of choice for the assessment of heart function in premature infants however however there is a significant lack of standardization, sensitivity, and reliability for echocardiography parameters and a lack of consensus regarding optimal detection timing. In adults and older children it is known that early diagnosis and treatment, particularly before right side of the heart fails, is an important determinant of treatment success and survival. Diagnosis late in postnatal course for preterm infants remains a major barrier to timely and effective treatment. The primary objective of this study is to develop new, sensitive, quantitative echocardiographic diagnostic criteria which will allow for the identification of extreme preterm neonates suffering from significantly high pressure in their pulmonary blood vessels, early in postnatal course, when the disease is likely to be most amenable to preventative/curative treatment. This is an international initiative that will leverage expertise about echocardiography techniques and cardiopulmonary physiology of preterm infants.The results of this study will have an immediate impact on the day-to-day care of these highly vulnerable infants. The results will lead to increased awareness among clinicians, inform future surveillance protocols and diagnostic timing, and provide ideal preparation for future therapeutic trials.

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2017-08-31
Est. Completion 2024-04-01

Sponsor

Mount Sinai Hospital, Canada

7 total trials

What the Registry Record Tells You About NCT04402645

The ClinicalTrials.gov registry entry for NCT04402645 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mount Sinai Hospital, Canada, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT04402645 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04402645 about?

NCT04402645 is a clinical study titled "Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension". Chronic pulmonary hypertension (cPHT) is a serious cardiopulmonary disorder that causes low oxygen levels in the blood, difficulty in breathing and ultimately heart failure. Newborn babies born extremely premature frequently suffer from cPHT while receiving treatment in neonatal intensive care units...

What is the current status of trial NCT04402645?

This trial is currently completed. The enrollment target is 350 participants. The study started on 2017-08-31. Estimated completion is 2024-04-01.

Who is sponsoring clinical trial NCT04402645?

This trial is sponsored by Mount Sinai Hospital, Canada, which has 7 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.