In this study we want to determine the most adequate parameters (clinical, echocardiographic, Near Infrared Spectroscopy (NIRS) and B-type Natriuretic Peptide (BNP)) to diagnose a hemodynamic significant PDA. A second objective is to gather normal…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
With respect to PDA in preterm infants < 32 weeks of gestation, which is/are
the most reliable discriminating variables?
Subquestions:
• Which clinical signs are important?
• Which echocardiographic parameters are important?
• What is the contribution of Near Infrared Spectroscopy (NIRS)?
• What is the contribution of B-type Natriuretic Peptide (BNP)?
• Is a combination of variables (ie a *PDA-score/algoritm*) more indicative for
PDA as compared to a single variable?
As gold standard for the diagnosis of 'significant PDA' an indepent panel of
experts, consisting of 2 neontalogists and 1 pediatric cardiologist, will
retrospectively judge significance of the open ducts . They are of course
blinded for the clinical cours the child had.
Secondary outcome
1. normal range of left and right ventricular dimensions in preterm infants <
32 weeks of gestation during the first week of life
2. range of normal plasma levels of B-type Natriuretic Peptide (BNP) in preterm
infants < 32 weeks of gestation during the first week of life
Background summary
Till date there is still contradicting evidence about the definition, diagnosis
and role of a hemodynamic significant PDA in preterm infants.
Study objective
In this study we want to determine the most adequate parameters (clinical,
echocardiographic, Near Infrared Spectroscopy (NIRS) and B-type Natriuretic
Peptide (BNP)) to diagnose a hemodynamic significant PDA.
A second objective is to gather normal echocardiographic values of left and
right ventricular dimensions and values of B-type Natriuretic Peptide (BNP) in
this population.
Study design
a prospective, observational cohort study in all preterm infants < 32 weeks of
gestation. The expected study period will be from October 1 2009 - October 1
2010.
Study burden and risks
little additional burden and/or risk: except for measurement of BNP 3x 50
microliters of extra blood will be taken from the group of clinical
non-suspected PDA and of all preterms < 32 weeks <24 hours postpartum: since
this is always taken during regular lab rounds and from an already present
indwelling line, it means little extra burden.
Lundlaan 6
3584 EA Utrecht
Nederland
Lundlaan 6
3584 EA Utrecht
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24499.041.09 |