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Factors to Consider to Study Preductal Oxygen Saturation Targets in Neonatal Pulmonary Hypertension
Heather Siefkes1, Sherzana Sunderji1, Jessica Vaughn1
1Department of Pediatrics, University of California, Davis, Sacramento, CA 95817, USA.
Insights
Higher oxygen saturation targets (95-99%) may reduce pulmonary vascular resistance in newborns with pulmonary hypertension (PH) and hypoxic respiratory failure (HRF). This pilot study compares high versus standard SpO2 targets to inform optimal infant care.
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
- Respiratory Physiology
Background:
- Optimal oxygen saturation (SpO2) targets for neonates with pulmonary hypertension (PH) and hypoxic respiratory failure (HRF) are undetermined.
- High SpO2 may cause oxygen toxicity, while low SpO2 can increase pulmonary vascular resistance.
- Acidosis and hypothermia can exacerbate the risks associated with lower SpO2 targets.
Purpose of the Study:
- To compare the efficacy of high (95-99%) versus standard (91-95%) preductal SpO2 targets in neonates with HRF and acute PH (aPH).
- To assess the reliability of a novel HRF/PH score for future research.
- To evaluate trial feasibility and gather preliminary outcome data.
Main Methods:
- A randomized pilot trial involving late-preterm and term infants with HRF and aPH.
- Comparison of two preductal SpO2 target ranges: 95-99% (intervention) and 91-95% (standard).
- Assessment of pulmonary vascular resistance, pulmonary arterial pressures, and need for pulmonary vasodilators (inhaled nitric oxide, milrinone, sildenafil).
Main Results:
- Hypothesis: Higher SpO2 targets will decrease pulmonary vascular resistance and the need for pulmonary vasodilators.
- Exploration of potential adverse effects of higher SpO2, including oxidative stress and reduced response to inhaled nitric oxide (iNO).
- Feasibility and reliability data for the HRF/PH score will be collected.
Conclusions:
- This study aims to establish optimal SpO2 targets for neonates with PH and HRF.
- Findings will guide larger clinical trials and inform treatment protocols for critically ill newborns.
- Understanding the balance between oxygenation benefits and risks is crucial for infant outcomes.
Abstract:
There are potential benefits and risks to the infant with higher and lower oxygen saturation (SpO2) targets, and the ideal range for infants with pulmonary hypertension (PH) remains unknown. Targeting high SpO2 can promote pulmonary vasodilation but cause oxygen toxicity. Targeting lower SpO2 may increase pulmonary vascular resistance, especially in the presence of acidosis and hypothermia. We will conduct a randomized pilot trial to compare two ranges of target preductal SpO2 in late-preterm and term infants with hypoxic respiratory failure (HRF) and acute pulmonary hypertension (aPH) of the newborn. We will assess the reliability of a newly created HRF/PH score that could be used in larger trials. We will assess trial feasibility and obtain preliminary estimates of outcomes. Our primary hypothesis is that in neonates with PH and HRF, targeting preductal SpO2 of 95-99% (intervention) will result in lower pulmonary vascular resistance and pulmonary arterial pressures, and lower the need for pulmonary vasodilators (inhaled nitric oxide-iNO, milrinone and sildenafil) compared to targeting SpO2 at 91-95% (standard). We also speculate that a higher SpO2 target can potentially induce oxidative stress and decrease response to iNO (oxygenation and pulmonary vasodilation) for those patients that still require iNO in this range. We present considerations in planning this trial as well as some of the details of the protocol design (Clinicaltrials.gov (NCT04938167)).
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