Longitudinal microcirculatory changes in newborns with Congenital Diaphragmatic Hernia; an observational study

Longitudinal microcirculatory changes in newborns with Congenital Diaphragmatic Hernia; an observational study - Microcirculatory changes in CDH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34367

Enrollment

120

Registered

2010-08-05

Start date

2010-08-23

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Congenital Diaphragmatic Hernia

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Group 1: CDH patients - Antenatal diagnosis of CDH - Mother admitted to Obstetrics & Gynecology department, Erasmus MC-Sophia - Parental informed consent ;Group 2: Control patients Group 2A - Control patients for group 1, matched for gender, PMA (±1 week) and age (± 1 day). - Admittance to IC of Erasmus MC-Sophia - Congenital malformations of the digestive tract - Parental informed consent;Group 2B - Control patients for group 1, matched for gender, PMA (±1 week) and age (± 1 day). - Born in the Obstetrics & Gynecolgy department of Erasmus MC-Sophia - Mother admitted to the Obstetrics & Gynecolgy department of Erasmus MC-Sophia - Parental informed consent

Exclusion criteria

Exclusion criteria: Group 1: CDH patients - Non-antenatal diagnosis of CDH - Outborn CDH patients - Recurrent CDH - Lung pathology mimicking diagnostic or clinical signs of CDH (diseases which should be excluded are diaphragmatic eventration, congenital cystic adenomatoid malformation (CCAML), bronchopulmonary sequestration, bronchogenic cysts, bronchial atresia, enteric cysts and teratomas) - Severe chromosomal anomaly (i.e. trisomy 13 or trisomy 18), which imply abstinence of therapy - Severe congenital cardiac anomaly (i.e. transposition of the great arteries, double outlet right ventricle, truncus arteriosus) with the exception of cardiac deformations associated with CDH (i.e. PDA, patent foramen ovale (PFO), small atrioventricular (AVSD) or atrioseptal defect (ASD)) - Cardiopulmonary resuscitation and subsequent therapeutic hypothermia;Group 2: Control patients Group 2A & Group 2B - Congenital anomalies or pathology of any kind known to influence cardiorespiratory functioning - Use of vasopressor(s) (i.e. dobutamine, dopamine, epinephrine, norepinephrine) and/or iNO therapy

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the incidence of ECMO dependency within the first day 28 of life and mortality within the first day 186 of life. Microcirculatory perfusion (depicted by PVD & MFI) will be assessed within 1 hour after admission for its predictive value.	—

Secondary

Measure	Time frame
To study microcirculatory perfusion in CDH patients on day 1 to 7 of life. To study the effects of dobutamine, dopamine, epinephrine, norepinephrine (in relation to the vasopressor score) and iNO on microcirculatory perfusion in CDH patients. To study the relation between microcirculatory perfusion (as measured by SDF) and routinely obtained macrocirculatory and microcirculatory parameters in CDH patients.	—

Measure

Time frame

To study microcirculatory perfusion in CDH patients on day 1 to 7 of life. To study the effects of dobutamine, dopamine, epinephrine, norepinephrine (in relation to the vasopressor score) and iNO on microcirculatory perfusion in CDH patients. To study the relation between microcirculatory perfusion (as measured by SDF) and routinely obtained macrocirculatory and microcirculatory parameters in CDH patients.

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Countries

Netherlands

Outcome results