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

Completed

Conditions studied: Pulmonary Hypertension, Infant, Premature

In brief

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.

Key facts

Study ID

NCT04402645

Run by

Mount Sinai Hospital, Canada

People needed

350

Starts

2017-08-31

Expected to finish

2024-04-01

Last updated by the study team

2024-06-14

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age at birth ≤26+6/7 and/or birth weight <1000g
• Alive at two weeks of postnatal age
• Infant cleared by the clinical team for approach

You may not qualify if…

• Known major congenital and/or genetic anomaly
• Congenital heart defects (CHD) except patent ductus arteriosus (PDA), patent foramen ovale (PFO), peripheral pulmonary artery stenosis and small (< 3 mm in diameter) ventricular septal defects
• Any condition which, in the opinion of the investigator, would preclude enrollment

Where it is running

• University of Iowa Health Care — Iowa City, Iowa, United States
• BC Women's Hospital & Health Centre — Vancouver, British Columbia, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Rotunda Hospital — Dublin, Ireland
• Liverpool — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.