Table 3 Exploratory outcomes
PBCC (n = 70) | ICC (n = 70) | |
|---|---|---|
Treatment related exploratory outcomes | ||
Protocol violations (yes/no) | n (%) | n (%) |
Time interval between birth and positioning of the baby on the resuscitation table (s) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Time interval between birth and start of respiratory support (s) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Time interval between birth and time to ‘stable’ (heart rate > 100 bpm, saturation > 85%, and FiO2 < 0.5; s) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Time interval between birth and cord clamping (s) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Maternal exploratory outcomes | ||
Estimated maternal blood loss during delivery (ml) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Need for blood transfusion during admission (yes/no) | n (%) | n (%) |
Surgical site infection after caesarean section (yes/no) | n (%) | n (%) |
Other maternal morbidity (yes/no) | n (%) | n (%) |
Neonatal exploratory outcomes | ||
Highest oxygenation index in the first 24 h | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Highest pre-postductal SpO2 difference in the first 24 h (%) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Number of criteria for pulmonary hypertension present | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Systemic blood pressure during echocardiography (mmHg) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
ECMO duration (days) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
ECMO complications (yes/no) | n (%) | n (%) |
Pulmonary hypertension requiring therapy at: | ||
- Day 7 (yes/no) | n (%) | n (%) |
- Day 14 (yes/no) | n (%) | n (%) |
- Day 21 (yes/no) | n (%) | n (%) |
- Day 28 (yes/no) | n (%) | n (%) |
- Discharge (yes/no) | n (%) | n (%) |
Use of pulmonary vasodilators: | ||
- Sildenafil (yes/no) | n (%) | n (%) |
◦ Number of days | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Prostaglandin E (yes/no) | n (%) | n (%) |
◦ Number of days | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Bosentan (yes/no) | n (%) | n (%) |
◦ Number of days | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Prostacyclins (yes/no) | n (%) | n (%) |
◦ Number of days | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Milr◦ inone (yes/no) | n (%) | n (%) |
◦ Number of days | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- iNO (yes/no) | n (%) | n (%) |
◦ Number of days | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
◦ Response to iNO (yes/no) | n (%) | n (%) |
◦ iNO started as routine management (yes/no) | n (%) | n (%) |
Use of inotropes in the first 72 h: | ||
- Adrenalin (yes/no) | n (%) | n (%) |
◦ Maximum dosage (mcg/kg/min) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Dobutamine (yes/no) | n (%) | n (%) |
◦ Maximum dosage (mcg/kg/min) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Dopamine (yes/no) | n (%) | n (%) |
◦ Maximum dosage (mcg/kg/min) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Milrinone (yes/no) | n (%) | n (%) |
◦ Maximum dosage (mcg/kg/min) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Noradrenalin (yes/no) | n (%) | n (%) |
◦ Maximum dosage (mcg/kg/min) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Vasopressin (yes/no) | n (%) | n (%) |
◦ Maximum dosage (units/kg/min) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Administration of a bolus of fluid in the first 24 h (yes/no) | n (%) | n (%) |
Frequency of bolus of fluid in first 24 h | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Total volume of fluid therapy in the first 24 h (ml/kg) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Culture proven early onset sepsis < 72 h (yes/no) | n (%) | n (%) |
- Start day | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Culture proven late onset sepsis > 72 h (yes/no) | n (%) | n (%) |
- Start day | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Hyperbilirubinemia requiring therapy (yes/no) | n (%) | n (%) |
- Maximum bilirubin level (mg/dl) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Phototherapy (yes/no) | n (%) | n (%) |
- Duration of phototherapy (days) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Exchange transfusion (yes/no) | n (%) | n (%) |
Cerebral complications: | ||
- Haemorrhage (yes/no) | n (%) | n (%) |
- Infarction (yes/no) | n (%) | n (%) |
- Other (yes/no) | n (%) | n (%) |
Surgical repair diaphragm (yes/no) | n (%) | n (%) |
Day of surgery | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Use of patch during surgery (yes/no) | n (%) | n (%) |
Surgical approach: | ||
- Laparotomic (yes/no) | n (%) | n (%) |
- Thoracoscopic (yes/no) | n (%) | n (%) |
- Laparoscopic (yes/no) | n (%) | n (%) |
Diaphragmatic defect size [18]: | ||
- A | n (%) | n (%) |
- B | n (%) | n (%) |
- C | n (%) | n (%) |
- D | n (%) | n (%) |
- Unknown | n (%) | n (%) |
Number of days on: | ||
- NIPPV/NIV (days) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- CPAP/high flow > 2 L (days) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
- Low flow ≤ 2 L (days) | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Oxygen dependency on day 28 (yes/no) | n (%) | n (%) |
Participation in other randomised controlled trials (yes/no) | n (%) | n (%) |
Number of days on intensive care unit | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |
Discharge without oxygen dependency (yes/no) | n (%) | n (%) |
Discharged on pulmonary vasodilators (yes/no) | n (%) | n (%) |
Discharged with palliative care (yes/no) | n (%) | n (%) |
Number of days alive if death before discharge | Mean ± SD or median [IQR] | Mean ± SD or median [IQR] |