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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: Completed study, sponsored by Mount Sinai Hospital, Canada.
NCT04402645 is a clinical trial that has completed, run by Mount Sinai Hospital, Canada. The registered enrollment target is 350 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sensitivity, specificity, positive and negative likelihood ratios for TAPSE and PAAT at each early diagnostic assessment against diagnosis of chronic pulmonary hypertension on standard diagnostic assessment using echocardiography using current standard criteria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2024-04-01 |
What the finished NCT04402645 record still lists
NCT04402645 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04402645 does not publish any study locations in the registry export this page uses.
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.
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