The Haemodynamic Significant Patent Ductus Arteriosus (PDA) in preterm infants: significance of different echocardiographic markers, clinical signs, Near Infrared Spectroscopy (NIRS) and B-type Natriuretic Peptide (BNP).
Completed
- Conditions
- open Ductus Botalli (ODB)persisting connection between pulmonary artery and systemic artery1002892010082206
- Registration Number
- NL-OMON33822
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
Preterm babies born before 32 weeks of gestation admitted to the NICU of the WKZ/UMCU
Exclusion Criteria
Preterm babies with congenital cardiac malformations, chromosomal abnormalities or gross cerebral congenital abnormalities
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>With respect to PDA in preterm infants < 32 weeks of gestation, which is/are<br /><br>the most reliable discriminating variables?<br /><br>Subquestions:<br /><br>• Which clinical signs are important?<br /><br>• Which echocardiographic parameters are important?<br /><br>• What is the contribution of Near Infrared Spectroscopy (NIRS)?<br /><br>• What is the contribution of B-type Natriuretic Peptide (BNP)?<br /><br>• Is a combination of variables (ie a *PDA-score/algoritm*) more indicative for<br /><br>PDA as compared to a single variable?<br /><br><br /><br>As gold standard for the diagnosis of 'significant PDA' an indepent panel of<br /><br>experts, consisting of 2 neontalogists and 1 pediatric cardiologist, will<br /><br>retrospectively judge significance of the open ducts . They are of course<br /><br>blinded for the clinical cours the child had. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. normal range of left and right ventricular dimensions in preterm infants <<br /><br>32 weeks of gestation during the first week of life<br /><br>2. range of normal plasma levels of B-type Natriuretic Peptide (BNP) in preterm<br /><br>infants < 32 weeks of gestation during the first week of life</p><br>