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%.
Conditions
Interventions
Trade Name: Medical Oxygen
Product Name: 99.5 %v/v Medicinal gas, compressed
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: OXYGEN
CAS Number: 80937-33-3
Current Sponsor code: SUB14733
Sponsors
Royal College of Surgeons in Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows: • Maternal age 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. • The use of high flow oxygen is contraindicated in patients with chronic respiratory disease. • Pregnant women with congenital heart disease are high risk antenatal patients and will be excluded to avoid them being exposed to high flow oxygen and to avoid any misinterpretation of the NICOM. • High flow oxygen should be avoided in any person taking the medications bleomycin or amiodarone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to predict the occurrence of neonatal pulmonary hypertension by measuring the pulmonary artery reactivity to maternal hyperoxygenation in fetuses at risk of neonatal respiratory morbidity. ;Secondary Objective: The secondary objectives of the trial are to: 1. Assess vasoreactive response to maternal hyperoxygenation (MH) in utero. 2. Assess the ability of MH to predict the degree of pulmonary vasculopathy present prior to birth. 3. Evaluate if pulmonary artery (PA) reactivity to MH identifies fetuses that will develop pulmonary hypertension. 4. Predict neonatal survival and pulmonary hypertension by measurement of PA reactivity to MH in fetuses at risk of neonatal respiratory morbidity. 5. Assess serial changes in maternal haemodynamics (cardiac output (CO), stroke volume (SV) and systemic vascular resistance (SVR)) before, during and after MH. ;Primary end point(s): The primary endpoint is the occurrence pulmonary hypertension in the neonate measured using echocardiography on Day 1 and 2 of age. The presence of pulmonary hypertension in the neonate will be formally assessed with a neonatal echocardiogram performed at two separate time points, at 6-12hours of life and at 36-48 hours of life. Persistent pulmonary hypertension will be defined as a pulmonary pressure greater than two thirds the systemic pressure beyond the initial 12 hours of life. ;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Severity of pulmonary hypertension Composite of neonatal respiratory morbidity (Respiratory Distress Syndrome and Transient Tachypnea of the Newborn) Neonatal intensive care unit (NICU) admission 28 day survival Survival to discharge from hospital Umbilical Artery and vein pHs and base excess Neonatal interventions required: • Chest compressions • Intubation • Peak inspiratory pressure (PIP) • Mean arterial pressure (MAP) • Positive end expiratory pressure (PEEP) • Adrenaline bolus at birth • Hydrocortisone pre transfer • Inotrope infusion pre transfer • Nitric • Surfactant • High frequency oscillatory ventilation (HFOV) at birth • Intravenous antibiotics • Nitric oxide duration ;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Ireland
Contacts
Public ContactRCSI Education & Research Centre
Royal College of Surgeons in Ireland
Outcome results
None listed