University of Alabama at Birmingham
Samuel Gentle
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.
Bronchopulmonary Dysplasia
Pulmonary Hypertension
higher oxygen saturation target using Nellcor pulse oximetry sensors
lower oxygen saturation target using Nellcor pulse oximetry sensors
NA
Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and 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 1week of exposure A, infants will cross over to exposure B for 1 week 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 |
| Estimated Enrollment : | 39 participants |
| Masking : | SINGLE |
| Masking Description : | The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed. |
| Primary Purpose : | TREATMENT |
| Official Title : | Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension |
| Actual Study Start Date : | 2025-07-01 |
| Estimated Primary Completion Date : | 2029-07-01 |
| Estimated Study Completion Date : | 2030-07-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 1 Month to 5 Months |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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