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

NCT ID: NCT04938167

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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).

Conditions

Persistent Pulmonary Hypertension of the Newborn; Hypoxemic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard arm

target preductal SpO2 - 91 to 95%

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention arm

target preductal SpO2 - 95 to 99%

Group Type: EXPERIMENTAL

95% - 99% SpO2 target

Intervention Type: OTHER

If the infant is randomized to the intervention arm, the oxygen saturation goal will be changed from the standard goal of 91% - 95% to the experimental goal of 95%-99%. The treating medical team will then adjust the oxygen and respiratory support to maintain these goals (SpO2 alarm levels will be set at 93% and 100%).

Interventions

95% - 99% SpO2 target

If the infant is randomized to the intervention arm, the oxygen saturation goal will be changed from the standard goal of 91% - 95% to the experimental goal of 95%-99%. The treating medical team will then adjust the oxygen and respiratory support to maintain these goals (SpO2 alarm levels will be set at 93% and 100%).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Corrected gestational age (postmenstrual age) > 34 6/7 weeks
• postnatal age ≤ 28 d
• on respiratory support with invasive mechanical ventilation, non-invasive ventilation, CPAP or high flow nasal cannula (defined as flow rates ≥ 2 LPM with a humidifier), inspired oxygen concentration, FiO2 ≥ 0.3
• and echocardiography shows any finding suggestive of PH (or score > 0 for PH in table 2).
• Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemic encephalopathy (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 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 death during infancy) - e.g., trisomy 18 or trisomy 13
• Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) < 2 mm.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California-Davis

Sacramento, California, United States

Countries

United States

References

Siefkes H, Sunderji S, Vaughn J, Sankaran D, Vali P, Vadlaputi P, Timberline S, Bhatt A, Tancredi D, Lakshminrusimha S. Factors to Consider to Study Preductal Oxygen Saturation Targets in Neonatal Pulmonary Hypertension. Children (Basel). 2022 Mar 11;9(3):396. doi: 10.3390/children9030396.

Reference Type: DERIVED

PMID: 35327768 (View on PubMed)

Related Links

https://studypages.com/s/testing-levels-of-oxygen-in-newborns-with-pulmonary-hypertension-800422/

Learn more or sign up for the study here!

Other Identifiers

5KL2TR001859-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1766675

Identifier Type: -

Identifier Source: org_study_id