Bronchopulmonary Dysplasia, Pulmonary Hypertension
Conditions
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 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.
Interventions
DEVICEhigher oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the higher oxygen saturation target.
DEVICElower oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the lower oxygen saturation target.
Sponsors
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Intervention model description
Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 1 week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period.
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Months
Healthy volunteers
Yes
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 mature retinas
Exclusion criteria
* Major congenital anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intermittent hypoxemia event duration | From date of randomization until 3 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic shunting | through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first | \>20% flow of blood across the PDA from the pulmonary to arterial circulation |
| Echocardiographic interventricular septal flattening | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first | End-systolic flattening of the interventricular septum (eccentricity index \>1.3) |
| Echocardiographic tricuspid regurgitation | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first | Right ventricular pressure estimates |
| Intermittent hypoxemia frequency | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first | Number of daily events during which an infant's oxygen saturation decreases below 80% |
| Cumulative hypoxemia | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first | Daily duration during which an infant's oxygen saturation is \<80% |
| Brain natriuretic peptide | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first | A polypeptide released from the cardiac ventricles indicative of right heart strain |
Countries
United States
Contacts
CONTACTSamuel Gentle, MD
CONTACTColm Travers
PRINCIPAL_INVESTIGATORSamuel Gentle
Yale University
Outcome results
None listed