Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension? - HOTPOT

Royal College of Surgeons in Ireland0 sites60 target enrollmentAugust 11, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occurs when there is a failure of the normal circulatory transition in the early newborn period. Persistence of the fetal circulation occurs,resulting in pulmonary hypertension,low oxygen levels and marked right-to-left shunting of blood in the newborn heart. Mortality ranges from 4 to 33%.
Sponsor: Royal College of Surgeons in Ireland
Enrollment: 60
Status: Active, Not Recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

August 11, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•The inclusion criteria can be divided into 3 main categories:
•A)Those at risk of respiratory morbidity at term
•Iatrogenic elective Caesarean section being performed \< 38 gestational weeks in an otherwise well baby. This subgroup will be informative in relation to circulatory adaptation close to term.
•B)Those at risk of pulmonary hypoplasia
•Patients with mid trimester PPROM
•Patients with persistent oligohydramnios of renal or nonrenal origin
•Patients whose fetuses have known: Congenital diaphragmatic hernia (CDH), Congenital cystic adenomatoid malformation (CCAM)
•Other space occupying lesions of the thorax (cardiomegaly, pleural effusion and skeletal dysplasia).
•C)Those at risk of respiratory morbidity due to a cardiac cause
•Women whose fetuses have a prenatal diagnosis of moderate/severe perimembranous ventricular septal defect (VSD)/atrioventricular septal defect (AVSD) in the absence of other structural heart disease including cases of Trisomy 21\. The MH test may contribute to prediction of the need for neonatal intervention in this group.

•The exclusion criteria are as follows:
•Maternal age \< 18 years
•Known fetal chromosomal abnormality excluding Trisomy 21
•Gestational age \<31 weeks and \>40 weeks
•Maternal chronic respiratory disease (including COPD, Cystic Fibrosis, Pulmonary Fibrosis)
•Maternal congenital heart disease
•Maternal use of bleomycin or amiodarone
•The justification for the exclusion criteria are as follows:
•An adult is defined as a person aged 18 years or over.
•The literature indicates that maternal hyperoxygenation does not alter fetal pulmonary circulation until after 31 weeks and therefore we will perform the test after 31 weeks gestation.