congenital diaphragmatic hernia/congenitale hernia diafragmatica/ventilation/beademing/neonates/neonaten/newborns/pasgeborenen/chronic lung disease/ bronchopulmonary dysplasia/ bronchopulmonaire dysplasie/high frequency oscillatory ventilation
Conditions
Interventions
After delivery, the patient will be intubated immediately and receive the allocated ventilation strategy (high-frequency oscillatory ventilation or conventional ventilation). Vital functions will be m
Sponsors
ErasmusMC-Sophia
P.O. Box 2060
3000 CB Rotterdam
the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newborn children antenatally diagnosed with congenital diaphragmatic hernia 2. The children are born in one of the participating centres 3. The children are born at or after a gestational age of 34 weeks 4. Prenatal informed consent 5. High-risk infants who received a fetal intervention may be included 6. Infants small for gestational age may be included
Exclusion criteria
Exclusion criteria: 1. Infants born with a severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop further life-saving medical treatment 2. Infants born with a severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life 3. Infants born with renal anomalies associated with oligohydramnios 4. Infants born with severe orthopaedic and skeletal deformities which are likely to influence thoracic and / or lung development 5. Infants born with severe anomalies of the central nervous system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death at day 28 and/or oxygen dependency at day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Severity of chronic lung disease according to the Bancalari definition: o Determined in children having oxygen use at day 28 o Point of assessment of severity of chronic lung disease at day 56 or discharge whichever comes first: § Mild: breathing room air § Moderate: need for < 30 % oxygen § Severe: need for ≥ 30 % oxygen and/or positive pressure by mechanical ventilation or CPAP • Number of ventilator-free days at day 30 • Number of ventilator-free days at day 60 | — |
Contacts
Public ContactLieke Hout, van den
ErasmusMC-Sophia Room Sp-2480 P.O. Box 2060
Outcome results
None listed