Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373289
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-19
Brief Title:
Target Oxygen Ranges in Infants With Pulmonary Hypertension
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TORPH
Brief 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
Detailed Description:
Infants born between 220 to 316 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 11 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
Using a cross over design with a 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23HD113837-01A1 | OTHER | NICHD pending | None |