Target Oxygen Ranges in Infants With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— TORPH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373289
• Other study ID #: 000539476
• Secondary ID: 1K23HD113837-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2025
• Est. completion date: July 1, 2030

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Samuel Gentle, MD
• Phone: 205-541-2247
• Email: samjgentle[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: July 1, 2030
• Est. primary completion date: July 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• higher oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the higher oxygen saturation target.
• lower oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the lower oxygen saturation target.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermittent hypoxemia event duration	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	Echocardiographic shunting	>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
Secondary	Echocardiographic interventricular septal flattening	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
Secondary	Echocardiographic tricuspid regurgitation	Right ventricular pressure estimates	From date of randomization until 5 weeks have elapsed or date of discharge, whichever came first
Secondary	Intermittent hypoxemia frequency	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
Secondary	Cumulative hypoxemia	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
Secondary	Brain natriuretic peptide	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