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

NCT04938167 | Active Not Recruiting DMC

• 2 other identifiers: 17666755KL2TR001859-04
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pulmonary Hypertension of the Newborn; Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  At enrollment

• Correlation of the Oxygenation and Echocardiography components of the HRF/PH scores

  At enrollment

Secondary Outcomes (2)

• Intracluster correlation coefficients of the HRF/PH score

  Days 3-7

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

  Day 7

Study Arms (2)

Standard arm

NO INTERVENTION

target preductal SpO2 - 91 to 95%

Intervention arm

EXPERIMENTAL

target preductal SpO2 - 95 to 99%

Other: 95% - 99% SpO2 target

Interventions

95% - 99% SpO2 target 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%).

Intervention arm

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 35327768 DERIVED

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized assignment to Standard arm (target preductal SpO2 91% to 95%) or Intervention arm (target preductal SpO2 95% to 99%)

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)