Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension

Phase

N/A

Condition

Circulation Disorders

Lung Injury

Pulmonary Arterial Hypertension

Treatment

95% - 99% SpO2 target

Clinical Study ID

NCT04938167

1766675

5KL2TR001859-04

Ages < 28
All Genders

Study Summary

The purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Corrected gestational age (postmenstrual age) > 34 6/7 weeks
postnatal age ≤ 28 d
on respiratory support with invasive mechanical ventilation, non-invasiveventilation, CPAP or high flow nasal cannula (defined as flow rates ≥ 2 LPM with ahumidifier), inspired oxygen concentration, FiO2 ≥ 0.3
and echocardiography shows any finding suggestive of PH (or score > 0 for PH intable 2).
Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemicencephalopathy (HIE) on therapeutic hypothermia and patent ductus arteriosus (PDA),patent foramen ovale/atrial septal defect (PFO/ASD) and ventricular septal defect (VSD) (single or multiple) < 2 mm can be included in the study.

Exclusion

Exclusion Criteria:

< 32 weeks gestation at birth (31 6/7 or lower)
Weight < 2000 g at the time of enrollment
Severe HRF with OI > 35 or SpO2 < 75% on FiO2 = 1.0 on mechanical ventilation for > 60 minutes in spite of correction of reversible factors such as pneumothorax
A condition or congenital anomaly known to be lethal (high likelihood of deathduring infancy) - e.g., trisomy 18 or trisomy 13
Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) < 2 mm.

Study Design

95% - 99% SpO2 target

August 01, 2021

December 31, 2025

Study Description

Successful transition at birth is dependent on establishment of lungs as the organ of gas exchange. Breathing at birth and an increase in alveolar oxygen tension (PAO2) leads to an 8-10 fold increase in pulmonary blood flow with a marked reduction in pulmonary vascular resistance (PVR). Failure to decrease PVR at birth results in hypoxemic respiratory failure (HRF) and persistent pulmonary hypertension of the newborn (PPHN). Hypoxemia exacerbates PPHN by increasing PVR. However, administration of excess oxygen in animal studies has been shown to increase free radical formation and reduce response to pulmonary vasodilators such as inhaled nitric oxide (iNO).

Thus, there is potential for benefit and also poor outcomes at both higher and lower oxygen saturations (SpO2), with the ideal range being unknown. The investigators will conduct a randomized unblinded, pilot trial to compare two ranges of target preductal SpO2 in late preterm and term infants with HRF or PPHN. During this trial the investigators will assess the reliability of a hypoxic respiratory failure/pulmonary hypertension (HRF/PH) score that could then be used in a larger clinical trial. The investigators will also assess trial feasibility and obtain preliminary estimates of outcomes. Our central hypothesis is that neonates with pulmonary hypertension (PH) and/or HRF, targeting preductal SpO2 of 95-99% (intervention) will result in lower PVR and lower need for non-oxygen based pulmonary vasodilators (iNO, milrinone and sildenafil) compared to a target of 91-95% (standard).

Connect with a study center

University of California-Davis
Sacramento, California 95817
United States
Site Not Available

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