CDH congenital diaphragmatic hernia
Conditions
Interventions
Conventional mechanical ventilation (CMV) will be provided by a neonatal
ventilator capable of positive pressure ventilation or triggered modes.
High frequency oscillatory ventilation (HFO) will be
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: •Antenatal diagnosis of congenital diaphragmatic hernia •Prenatal informed consent •The children are born in one of the participating centres •The children are born at or after a gestational age of 34 weeks •Infants who received a foetal intervention may be included
Exclusion criteria
Exclusion criteria: •Infants with a severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop further life-saving medical treatment •Infants born with a severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life (such as transposition of the great arteries or double outlet right ventricle) •Infants born with renal anomalies associated with oligohydramnios •Infants born with severe orthopaedic and skeletal deformities which are likely to influence thoracic and / or lung development (such as chest wall deformities and spine anomalies) •Infants born with severe anomalies of the central nervous system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygen dependency at day 28 and/or death within the first 28 days of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Overall mortality in the first year of life •Number of treatment failures, see paragraph 6.5 failure criteria and switching •Severity of chronic lung disease using the Bancalari definition (see Appendix V). •Number of days on a ventilator •Severity of pulmonary hypertension according to echocardiographic parameters •Medical treatment for pulmonary hypertension during the hospital admission •The level of specific laboratory markers, urine desmosine and proteomic analysis of tracheal aspirates, up to day 28, to describe the severity of ventilator-induced lung injury •Requirement of pulmonary and/or cardiac medication at discharge and/or during the first year of life •Long-term pulmonary outcome, described as pulmonary function at the age of 6 and 12 months, diary card documented respiratory morbidity and healthcare utilisation •Requirement of ECMO (only described for ECMO-centres) (see also paragraph 6.1) | — |
Countries
Netherlands
Outcome results
None listed