Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia
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| First Received Date ICMJE | January 19, 2012 | ||||||||
| Last Updated Date | April 4, 2012 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01516398 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia | ||||||||
| Official Title ICMJE | Endothelin-1 (ET-1) and Brain Natriuretic Peptide (BNP) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD) | ||||||||
| Brief Summary | A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes and death for premature infants. Infants with BPD are also at high risk for pulmonary hypertension (PH)—an important contributor to their condition. Previous research has suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary disease. This study aims to investigate the incidence of incidence of PH and levels of ET-1 among premature babies with BPD. It will also potentially allow us to focus further research efforts and treatment towards these infants, some of our sickest patients at LPCH.This study aims to 1) investigate the incidence of PH among premature infants with BPD versus those without BPD; 2) investigate ET-1 levels in infants with BPD-associated PH versus those without BPD-associated PH; and 3) investigate BNP (brain natriuretic peptide) values in infants with BPD-associated PH versus those without BPD-associated PH. This study will allow us to help define a high-risk population at LPCH—namely, premature infants with BPD-associated PH. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | LPCH premature neonates |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 30 Weeks | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01516398 | ||||||||
| Other Study ID Numbers ICMJE | BPD22044 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Stanford University | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Stanford University | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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