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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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