Assessing blood flow chracteristics across the foramen ovale in term infants during transition at birth: an observational study.

Assessing blood flow chracteristics across the foramen ovale in term infants during transition at birth: an observational study. - SHUNT study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57008

Enrollment

Registered

2023-11-30

Start date

2025-07-08

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

nvt.

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Only healthy term infants (37-42 weeks of gestation) of singleton multiparous low-risk pregnancies, delivered by spontaneous vaginal delivery, are eligible for measurements within the first minutes after birth.

Exclusion criteria

Exclusion criteria: Exclusion criteria are determined based on the acknowledgment of the stressful  nature of childbirth, particularly for primigravida mothers. Therefore, we  exclusively approach multiparous mothers, excluding those giving birth to their  first child. Additionally, patients with a gestational age of less than 37  weeks, high-risk pregnancies (including infants with known or suspected  anatomic malformations such as congenital heart disease (CHD) or pulmonary  diseases), and infants requiring respiratory support or supplemental oxygen  during the transition are excluded. This study solely includes infants who  experience an uncomplicated transitional period.

Design outcomes

Primary

Measure	Time frame
• Ultrasonographic doppler velocimetry measurements of blood flow through the FO, DA (to confirm the short circuit circulation) and LVOT (effect of cord clamping on cardiac output) will be measured and recorded immediately after birth while the infant remains attached to the umbilical cord. Moreover, measurements will be done after umbilical cord clamping.	—

Secondary

Measure	Time frame
• Diaphragm movements will be recorded simultaneously using ultrasonography to correlate respiratory activity with cardiovascular changes. This will help elucidate the impact of breathing on FO flow hemodynamics. • Lastly, electrocardiography (ECG) monitoring will be employed throughout the study to provide a comprehensive assessment of heart rate variability and its relationship to FO flow changes during the cardiac cycle (i.e. systolic and diastolic phase).	—

Measure

Time frame

• Diaphragm movements will be recorded simultaneously using ultrasonography to correlate respiratory activity with cardiovascular changes. This will help elucidate the impact of breathing on FO flow hemodynamics. • Lastly, electrocardiography (ECG) monitoring will be employed throughout the study to provide a comprehensive assessment of heart rate variability and its relationship to FO flow changes during the cardiac cycle (i.e. systolic and diastolic phase).

—

Countries

Netherlands

Contacts

Public ContactJ.A. Weeda

Leids Universitair Medisch Centrum

j.a.weeda@lumc.nl+31634127818

Outcome results