Congenital diaphragmatic hernia, pulmonary hypertension, transition, cord clamping, resuscitation, birth defect.
Conditions
Interventions
CDH infants randomized to the intervention group will be stabilized according to physiological-based cord clamping (PBCC). For PBCC a specially designed resuscitation table (the Concord) will be used.
Sponsors
Erasmus MC, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: Infants antenatal diagnosed with isolated left-sided CDH with gestational age at delivery =35.0 weeks, in the absence of major structural or genetic abnormalities diagnosed before birth.
Exclusion criteria
Exclusion criteria: - Right sided or bilateral CDH. - Major associated anomalies (structural and/or genetic). - Maternal contraindications of PBCC: anterior placenta praevia, placental abruption. - High urgency caesarean section, with intended interval to delivery less than 15 min. - Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension (such as sildenafil). - Twin pregnancies in which the infant diagnosed with a CDH is born first - Multiple birth > 2 (triplets or higher order).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary hypertension diagnosed in the first 24hrs after birth (binary variable). Pulmonary hypertension is present if at least 2 of the following 4 criteria are present or if the infant requires extracorporeal membrane oxygenation (ECMO) in the first 24 hours after birth - Right ventricular systolic pressure (RSVP) = 2/3 systemic systolic pressure; - Right ventricle (RV) dilatation/septal displacement, RV dysfunction +/- LV dysfunction; - Pre-post ductal SpO2 difference >10%; - Oxygenation Index >20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline characteristics: - Maternal - Fetal - Neonatal Treatment related: - Protocol violation - Time interval between birth and cord clamping (continuous variable) - Time interval between birth and start respiratory support Neonatal: - Survival at discharge - ECMO (and complications) (in survivors) - Pulmonary hypertension (in survivors) at day 7, 14, 21, 28, and at discharge - Use of pulmonary vasodilators (in survivors) (sildenafil, prostaglandin E, bosentan, prostacyclins, milrinone, iNO) -Response to treatment with iNO, defined as follows: a decline of 10–20% in the pre-postductal saturation difference, or an increase of 10–20% of PaO2, or improvement in hemodynamic parameters meaning a 10% increase in mean blood pressure, or a decrease in lactate levels. - Use of inotropes (in survivors) (adrenalin, dobutamine, dopamine, noradrenalin, vasopressin) - Use of fluid therapy in first 24 hours (in survivors) - Oxygen dependency on day 28 (in survivors) and severity of BPD - Early onset sepsis (in survivors) - Late onset sepsis (in survivors) - Hyperbilirubinemia requiring therapy (in survivors) (phototherapy, exchange transfusion) - Cerebral complications (in survivors) - Surgery (in survivors): day of surgery, use of patch, surgical approach, defect size - Number of days on intensive care unit (in survivors) - Number of days needing supplemental oxygen (in survivors) - Number of days on respiratory support (in survivors): mechanical ventilation, NIPPV/NIV, CPAP/high flow >2L, low flow =2L. - Discharge without oxygen dependency - Physiological parameters and ventilator settings in the first 72 hours after birth: NIRS, FiO2, mean airway pressure, ventilator mode, flow, heartrate, preductal and postductal SpO2, PaO2 and pH in arterial blood gas, NIBD, ABP. Echocardiographic parameters on first ultrasound in first 24 hours after birth: - RVSP - RV size - RV function - PAAT:RVET ratio - IVS configuration - LV-sEI - Tricuspid regurgitation and peak velocity - RV syst | — |
Contacts
Public ContactPhilip DeKoninck
Erasmus Medical Centre - Sophia Children's Hospital
Outcome results
None listed