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Persistent Pulmonary Hypertension of the NewbornPOST-ITNCT04938167

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

A study testing 95% - 99% SpO2 target in people with Persistent Pulmonary Hypertension of the Newborn and Hypoxemic Respiratory Failure, run by University of California, Davis at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 28 days
What is being tested?
95% - 99% SpO2 target
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
1 Aug 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • < 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California-Davis

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension (POST-IT)

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.

Read the 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).

Being tested
95% - 99% SpO2 target
Medical subject headings
Persistent Fetal Circulation Syndrome, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 95% - 99% SpO2 targetOther

    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%).

Study groups in NCT04938167
Study groupRoleWhat they receive
Standard armNo interventiontarget preductal SpO2 - 91 to 95%
Intervention armExperimentaltarget preductal SpO2 - 95 to 99%
Receives: Other: 95% - 99% SpO2 target

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypoxemic Respiratory Failure and Pulmonary Hypertension (HRF/PH) score

    Most randomized trials evaluating PPHN have taken oxygenation, echocardiographic evidence of PH or survival with extracorporeal membrane oxygenation (ECMO) as primary endpoints. Oxygenation was primarily assessed with postductal arterial gases. More recently, preductal SpO2 and blood gases have been shown to have advantages during management of PPHN with congenital diaphragmatic hernia (CDH). Given the low need for ECMO in PPHN (other than due to CDH), the investigators have developed a HRF/PH score combining oxygenation using preductal SpO2 and echocardiographic parameters. The score ranges from 0 to 15, with a higher score corresponding to worse respiratory failure or pulmonary hypertension. The primary aim of this pilot trial to understand the variation of this score at two oxygen saturation targets and assess its reliability and validity.

    Measured: At enrollment

  2. Correlation of the Oxygenation and Echocardiography components of the HRF/PH scores

    Measured: At enrollment

Secondary outcomes (2)

  1. Intracluster correlation coefficients of the HRF/PH score

    The investigators will fit a sequence of two-level multilevel models to estimate intracluster correlation coefficients based on the between-infant (level 2) and other relevant variance component(s), after adjusting for fixed effects, including study arm and sex. Interrater reliability at specific days will be estimated by having two or more raters (level 1) score each infant's underlying oxygenation and echocardiography measurements, while within-infant, over-time intracluster correlation will be estimated by analyzing a data set with one score per infant per day (level 1), with fixed effects added to account for day effects and possibly restricted to a smaller number of the later days (e.g. days 3 to 7), in case early-day values are grossly unstable.

    Measured: Days 3-7

  2. Preliminary estimates of intervention effects on outcomes (length of stay, duration of mechanical ventilation, and ECMO)

    For obtaining preliminary estimates of intervention effects on Day-7 HRF/PH, the investigators will use the results of Outcome 1 to inform our choice of how best to account for the baseline HRF/PH score, although the investigators anticipate that the within-infant correlation will be suitably modest that ANCOVA-like approaches will be preferred over differences-in-differences. Intervention effects and other regression-parameters will be estimated with robust 95% confidence intervals, to ensure accurate coverage.

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2021
  2. Study start1 Aug 2021
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized assignment to Standard arm (target preductal SpO2 91% to 95%) or Intervention arm (target preductal SpO2 95% to 99%)
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04938167
Sponsor's protocol ID
1766675
Other IDs
5KL2TR001859-04
Acronym
POST-IT
Status last verified
Apr 2026
First submitted
16 Jun 2021
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35327768

Questions about this trial

What is this clinical trial studying?

A study testing 95% - 99% SpO2 target in people with Persistent Pulmonary Hypertension of the Newborn and Hypoxemic Respiratory Failure, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypoxemic Respiratory Failure and Pulmonary Hypertension (HRF/PH) score (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04938167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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