It is hypothesized that advanced hemodynamic monitoring will result in earlier detection of circulatory failure in critically ill newborn infants compared to clinical assessment of shock, which is the actual standard diagnostic tool in daily…
ID
Source
Brief title
Condition
- Heart failures
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Timing (postnatal age) of diagnosis of circulatory failure (shock)
2. Agreement between objective cardiac output assessment by transpulmonary
ultrasound dilution (TPUD) and simultaneously clinically estimated cardiac
output (absolute and categorical)
Secondary outcome
Other hemodynamic parameters that will be analyzed are:
- regional oxygen saturation at the level of the brain, kidney, intestines and
muscle
- arterial blood pressure
- heart rate
- arterial oxygen saturation
- hemodynamic volumetry
Background summary
Circulatory failure is a main cause of serious morbidity and mortality in
critically ill newborn infants. Early detection of circulatory failure (shock)
is quite a challenge. Many methods of advanced hemodynamic monitoring have been
introduced in routine care in critically ill adults and larger children. Most
technologies, however, are not applicable in neonates. The hemodynamic status
of newborn infants is usually estimated by the interpretation of indirect
parameters of cardiac output, such as blood pressure, heart rate, color, urine
production et cetera. It has however been shown in adults and larger children
that this clinical assessment is inaccurate, irrespective of the level of
experience of the clinician. Most clinical signs and symptoms of neonatal
circulatory failure are rather subjective with a questionable reproducibility.
Comprehensive hemodynamic monitoring could has a reality in neonatal care
thanks to advances in medical technology. Our research group has gathered much
experience with the validation of transpulmonary ultrasound dilution (TPUD) in
many experimental animal studies. This showed that TPUD is applicable in
neonates under severe specific circumstances and conditions.
Study objective
It is hypothesized that advanced hemodynamic monitoring will result in earlier
detection of circulatory failure in critically ill newborn infants compared to
clinical assessment of shock, which is the actual standard diagnostic tool in
daily neonatal intensive care practice. Moreover, advanced hemodynamic
monitoring offers the unique opportunity to gather information about
cardiovascular (path)physiology in newborns.
Study design
Prospective observational cohort study
Study burden and risks
The risks for the newborn infant that participates in this study is negligible,
since it concerns a non-therapeutic, prospective observational cohort study in
which the patients will be comprehensively hemodynamically monitored with
medical equipment that received CE marking. Moreover, the hemodynamic variables
acquired with transpulmonary ultrasound dilution and/or near infrared
spectroscopy, are blinded for the attending physicians. This implies that
clinical decision-making is not different from non-participating patients or
daily practice.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Birth weight >=700 grams
- Arterial catheter in place, well functioning with tip adequately positioned in abdominal aorta (umbilical catheter), radial artery or posterior tibial artery
- Central venous catheter in place, non-silicone, well functioning with tip adequately positioned on the junction between right atrium and inferior vena cava or superior vena cava (multi-lumen, when a pause in the continuous intravenous administration of drugs (for example inotropes or vasopressors) is not possible; single-lumen, when the continuous administration of drugs can be stopped for the period of cardiac output measurements, approximately 5-6 minutes)
- Informed consent obtained from parents or representatives
Exclusion criteria
- Infants not meeting eligibility criteria
- Life-threatening congenital defects
- Congenital heart defects, except for patent ductus arteriosus and patent foramen ovale.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT01550198 |
| CCMO | NL38140.091.12 |