Longitudinal Patterns of Angiogenesis Biomarkers in Premature Infants that Predict Bpd
Study on Angiogenesis Biomarkers in Premature Infants with Lung Disease
Michelle C. Starr, MD
Primary Investigator
Brief description of study
The purpose of this study is to (1) characterize patterns of angiogenesis biomarkers in premature infants, and (2) describe patterns of molecular markers of angiogenesis in those with and without lung disease.
Detailed description of study
We will be collecting clinical and laboratory data gathered during hospitalization as part of routine clinical care. Specifically, we will collect available data to assess kidney disease (serum creatinine, urine output), lung disease (FiO2, oxygenation index, ventilatory support) and fluid status (daily weight).
URINE AND BLOOD SAMPLE COLLECTION: Urine will be collected at enrollment (within 3 days of admission), Days 5, 7, 9, 14, 21, 28. Additional urine collection will occur at 30 and 34 weeks post-menstrual age and at discharge. Urine will be obtained via a bladder catheter only if it was placed for clinical reasons. Otherwise, urine will be collected using a cotton ball placed near the perineum. Once collected, urine will be processed and stored frozen at -80C in the lab of Drs. Hains and Schwaderer. Blood samples (1mL each) will be collected at times of otherwise indicated clinical blood draw if deemed clinically tolerable by the attending neonatologist. Blood will be collected at enrollment, and at 7, 14, 21 and 28 days of life. Blood will also be collected at 30 and 34 weeks post-menstrual age and at hospital discharge.
TRACHEAL ASPIRATE COLLECTION: Tracheal aspirates will be obtained during routine suctioning of the endotracheal tube for airway hygiene via closed in line suction catheter. When indicated, suctioning will be performed by bedside RN or Respiratory Therapist. A specimen trap will be used to collect the tracheal aspirates. After ETT suctioning is completed, the specimen will be processed and stored in the Gaston Lab. Samples will be obtained at enrollment, then weekly during intubation and at hospital discharge.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Premature birth, Riley
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Age: 28 weeks or below
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Gender: All
Inclusion criteria:
- Individuals will be eligible for inclusion in this study if they are (a) born at <28 weeks’ gestation, (b) intubated within the first 48 hours of life and (c) enrolled within 72 hours of admission. Severe BPD will be defined by respiratory support at 36 weeks post-menstrual age.
Exclusion criteria:
- Individuals will be excluded from this study if their medical chart indicates severe congenital abnormalities of the kidney or urinary tract.
The purpose of this study is to investigate patterns of angiogenesis biomarkers in premature infants. Angiogenesis is the process by which new blood vessels form from pre-existing vessels. This study will look at these patterns in infants with and without lung disease, such as bronchopulmonary dysplasia (BPD), a condition often affecting premature babies' lungs.
In this study, doctors will collect clinical and laboratory data during the infants' hospital stay. They will gather urine and blood samples, as well as tracheal aspirates, which are fluids from the lungs. Urine will be collected at various times, and blood samples will be taken during routine blood draws. Tracheal aspirates will be collected during regular airway suctioning.
- Who can participate: Premature infants born at less than 28 weeks of gestation, who are intubated within the first 48 hours of life, and enrolled within 72 hours of admission can participate. Infants with severe congenital abnormalities of the kidney or urinary tract are excluded.
- Study details: A placebo is not used in this study.
