To explore cardiovascular remodelling with subsequent altered cardiac function (assessed as strain rate) in extremely premature neonates (born
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Altered cardiac function subsequent to cardiovascular remodelling in preterm
born FGR neonates compared to non-FGR preterm neonates, assessed as the left
ventricular longitudinal strain rate using STE. An altered cardiac function
will be defined as a left ventricular longitudinal strain rate that is
significantly different from the reference values of -1.6 - -1.9/s in the term
neonatal population, and -1.5 - -1.7/s in preterm neonates.
Secondary outcome
1) The association between early cardiac function and short-term morbidity
a. The development of PH.
b. The presence of impaired CAR and short-term cerebral injury (ultrasound and
general movements (GMs)).
c. The development of NEC, as a potential complication partly due to reduced
abdominal tissue oxygenation.
2) The relation between postnatal left ventricular longitudinal strain rate
with regular foetal cardiac assessment, and associated factors with the
postnatal delta strain rate
3) Maternal and neonatal risk factors including FGR for suboptimal cardiac
function, and associations with PH, impaired CAR, short-term morbidity;
neurodevelopmental outcome; mortality.
Background summary
NeoLifeS is an ongoing prospective observational cohort study in which data of
preterm born neonates admitted to the University Medical Center Groningen
(UMCG) are being collected from standard medical care. This study aims to
improve the quality of care for preterm born neonates.
NeoLifeS-Heart was a substudy in preterm born infants, that focused on the
cardiovascular problems affecting a substantial part of this patient
population, including early and late pulmonary hypertension. We now propose a
second substudy within NeoLifeS to assess cardiovascular complications in very
preterm born infants after fetal growth restriction (FGR), or small for
gestational age (SGA).
Preterm born neonates have an immature vascularization of various organs and
are therefore at risk of damage to several organ systems, such as the lungs
with bronchopulmonary dysplasia (BPD) and pulmonary hypertension (PH), the
intestines with necrotizing enterocolitis (NEC), and the brain with impaired
cerebrovascular autoregulation (CAR) and subsequent cerebral haemorrhage or
ischemia. Neonates born after FGR encounter even worse complications, in part
due to compensatory mechanisms, such as brain-sparing and increased cardiac
output resulting in cardiovascular remodelling. The worldwide incidence of FGR
is 7-10%. Depending on the definition and the birth weight, BPD prevalence
ranges between 23-57%, and the prevalence of PH lies between 8-18%.
Additionally, FGR neonates display impaired CAR more often than non-FGR
neonates. All these complications together negatively affect the quality of
life and survival of preterm born and FGR neonates. Knowledge regarding risk
factors, the incidence, prevalence, and occurrence of compensatory mechanisms
is lacking but necessary to improve patient care. This NeoLifeS-Heart II study
aims to explore these aspects of prematurity and FGR to guide optimized patient
care, improving the outcome and prognosis of this patient population.
Study objective
To explore cardiovascular remodelling with subsequent altered cardiac function
(assessed as strain rate) in extremely premature neonates (born <30 weeks
and/or birth weight < 1000 gram) with FGR.
Study design
Prospective case-control study
Study burden and risks
The data collected within NeoLifeS are part of standard medical care. In
addition to this, echocardiograms will be recorded within the first week after
birth (preferably up to and including day 4), and once for follow-up after
approximately 6 months during a visit to the outpatient clinic. During
admission to the neonatal intensive care unit (NICU), echocardiography is
performed at least once in approximately 25% of the patients for clinical
reasons. A part of these patients will receive follow-up echocardiography upon
their visit to the outpatient clinic. The echocardiograms for this study will
be combined with those performed for standard clinical procedures for the
neonatal echocardiographies. Any additional echocardiograms will only be
performed if this is clinically safe for the participant according to the
treating physician. The echocardiography will take approximately 30 minutes of
the patient*s time in total. A potential benefit for the participants is the
early detection and therefore earlier treatment of cardiac abnormalities.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Admission to the NICU of the UMCG
Gestational age <30 weeks and/or birth weight <1000 gram
Informed consent of the guardian/parent(s).
Exclusion criteria
Declined participation
Major chromosomal abnormalities/congenital abnormalities (such as abdominal
wall defects)
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 | NL82734.042.22 |