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NCT04402645
Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension
trial in Pulmonary Hypertension in 350 participants. Completed in 1 April 2024.
31 August 2022
Quick facts
| Lead sponsor | Mount Sinai Hospital, Canada |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 350 |
| Start date | 31 August 2017 |
| Primary completion | 31 August 2022 |
| Estimated completion | 1 April 2024 |
| Sites | 6 locations across Ireland, United Kingdom, Canada, United States |
Conditions studied
- Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
- Infant, Premature — all drugs for Infant, Premature →
Sponsor
Mount Sinai Hospital, Canada
Who can join
14 Days and older, any sex, with Pulmonary Hypertension or Infant, Premature. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Multicentre prospective observational study exploring the predictive value of functional echocardiographic indices for early identification of preterm neonates at risk of developing chronic pulmonary hypertension secondary to chronic neonatal lung disease.
Thomas L, Baczynski M, Deshpande P, Kharrat A, et al · · 2021 · cited 4× · PMID 33789855 · DOI 10.1136/bmjopen-2020-044924
Verify or expand the search:
- PubMed search for NCT04402645
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04402645 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mount Sinai Hospital, Canada
- Last refreshed: 14 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04402645.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing