Neonatal outcome after cardiovascular remodelling in fetal growth restriction

Neonatal outcome after cardiovascular remodelling in fetal growth restriction - NeoLifeS - Heart II

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51270

Enrollment

130

Registered

2022-09-30

Start date

2023-04-24

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delayed growth fetal growth restriction fetal growth restriction

Interventions

No additional intervention, participants undergo regular clinical care and two cardiac ultrasound examinations for this study.

Eligibility

Inclusion criteria

Inclusion criteria: Admission to the NICU of the UMCG Gestational age

Exclusion criteria

Exclusion criteria: Declined participation Major chromosomal abnormalities/congenital abnormalities (such as abdominal wall defects)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Contacts

Public ContactCL Brunsch

Universitair Medisch Centrum Groningen

c.l.brunsch@umcg.nl(050) 361 24 88

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026