Oxygen Saturation Target for Newborn Pulmonary Hypertension

(POST-IT Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Gestation < 32 weeks, Weight < 2000 g, Severe HRF, Lethal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

54 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment targeting 95% - 99% SpO2 for newborn pulmonary hypertension?

Research suggests that maintaining oxygen saturation levels in the low to mid 90s can help manage pulmonary hypertension in preterm infants by avoiding low oxygen levels (hypoxia) and high oxygen levels (hyperoxia). This approach is considered reasonable while awaiting further studies to provide more definitive guidance. ^{1 2 3 4 5}

Is targeting 95-99% oxygen saturation safe for newborns with pulmonary hypertension?

Research suggests that targeting higher oxygen saturation levels (95-99%) in newborns with pulmonary hypertension may help reduce lung pressure but could also lead to oxygen toxicity, which is harmful. The safety of this approach is still being studied, and potential risks include oxidative stress and decreased response to certain medications. ^{6 7 8 9 10}

How does the 95% - 99% SpO2 target treatment for newborn pulmonary hypertension differ from other treatments?

This treatment is unique because it specifically targets maintaining oxygen saturation levels between 95% and 99% to manage pulmonary hypertension in newborns, aiming to balance the risks of too little or too much oxygen. Unlike other approaches that may use a combination of oxygen saturation and arterial oxygen tension, this method focuses on a precise oxygen saturation range to optimize outcomes and minimize oxygen toxicity. ^{3 11 12 13 14}

What is the purpose of this trial?

This trial tests if keeping oxygen levels higher (95-99%) is better than slightly lower (91-95%) for newborns with lung problems. It aims to find the best oxygen range to help them breathe better and reduce lung pressure.

Eligibility Criteria

This trial is for newborns up to 28 days old with pulmonary hypertension or related conditions, needing respiratory support and oxygen. They must weigh over 2000g and be born after at least 32 weeks of gestation. Babies with certain heart defects or lethal conditions like trisomy 18 or trisomy 13 cannot participate.

Inclusion Criteria

My baby is 28 days old or younger.

My baby is more than 34 weeks and 6 days old, counting from conception.

My infant has CDH, Down syndrome, HIE, PDA, PFO/ASD, or VSD less than 2 mm.

Exclusion Criteria

My condition is often fatal in infancy, like trisomy 18 or 13.

I was born before reaching 32 weeks of pregnancy.

I have severe respiratory failure and have been on a ventilator for over an hour despite treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomly assigned to one of two oxygen saturation goals and monitored for changes in pulmonary hypertension and respiratory failure

7 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 95% - 99% SpO2 target

Trial Overview The study tests two different goals for blood oxygen levels (95%-99% SpO2) in newborns with pulmonary issues. Participants will be randomly assigned a target range, have their medical records reviewed, and undergo targeted echocardiograms to assess the effects.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

target preductal SpO2 - 95 to 99%

Group II: Standard arm Active Control 1 Intervention

target preductal SpO2 - 91 to 95%

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Novel scoring tool of hypoxemic respiratory failure and pulmonary hypertension for defining severity of persistent pulmonary hypertension of newborn. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Neonatal pulmonary hypertension. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Oxygen therapy in preterm infants with pulmonary hypertension. [2022]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension in neonates: does the cause influence the outcome? [2004]

5. England pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension in the newborn. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Morbidity of Persistent Pulmonary Hypertension of the Newborn in the First Year of Life. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Factors to Consider to Study Preductal Oxygen Saturation Targets in Neonatal Pulmonary Hypertension. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Target oxygen saturation and development of pulmonary hypertension and increased pulmonary vascular resistance in preterm infants. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Early risk factors for death in neonates with persistent pulmonary hypertension of the newborn treated with inhaled nitric oxide]. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Impact of Pulmonary Hypertension in Preterm Infants with Severe Bronchopulmonary Dysplasia through 1 Year. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Oxygen Therapy and Pulmonary Hypertension in Preterm Infants. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Management of Supplemental Oxygen for Infants with Persistent Pulmonary Hypertension of Newborn: A Survey. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Fetus Can Teach Us: Oxygen and the Pulmonary Vasculature. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Pulmonary Hypertension Associated with Hypoxic-Ischemic Encephalopathy-Antecedent Characteristics and Comorbidities. [2019]