Target Oxygen Ranges in Infants With Pulmonary Hypertension (TORPH)

April 17, 2024 updated by: Samuel Gentle, University of Alabama at Birmingham

Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension

Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have prethreshold retinopathy of prematurity in at least one eye or have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention).

Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 2 weeks of exposure A, infants will cross over to exposure B for 2 weeks with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. Reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between 22w 0/7d and 31w 6/7d gestation at birth
  • Diagnosed with echocardiographic pulmonary hypertension (1) >20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index >1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg
  • Receiving supplemental oxygen
  • Have prethreshold retinopathy of prematurity in at least one eye or have mature retinas

Exclusion Criteria:

  • Major congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxygen saturation target 92-95%
At UAB oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 92-95% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed for a 2 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.
Device: lower oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the lower oxygen saturation target.
Active Comparator: Oxygen saturation target 95-98%
At UAB oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 95-98% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed for a 2 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.
Device: higher oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the higher oxygen saturation target.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermittent hypoxemia event duration
Time Frame: From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%.
From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic shunting
Time Frame: through study completion, 5 weeksFrom date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
>20% flow of blood across the PDA from the pulmonary to arterial circulation
through study completion, 5 weeksFrom date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Echocardiographic interventricular septal flattening
Time Frame: From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
End-systolic flattening of the interventricular septum (eccentricity index >1.3)
From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Echocardiographic tricuspid regurgitation
Time Frame: From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Right ventricular pressure estimates
From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Intermittent hypoxemia frequency
Time Frame: From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Number of daily events during which an infant's oxygen saturation decreases below 80%
From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Cumulative hypoxemia
Time Frame: From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Daily duration during which an infant's oxygen saturation is <80%
From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Brain natriuretic peptide
Time Frame: From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
A polypeptide released from the cardiac ventricles indicative of right heart strain
From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Samuel Gentle, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000539476
  • 1K23HD113837-01A1 (Other Identifier: NICHD (pending))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Hypertension

Clinical Trials on lower oxygen saturation target using Nellcor pulse oximetry sensors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe