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Table 1 Baseline characteristics

From: Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan

 

PBCC (n = 70)

ICC (n = 70)

Maternal baseline characteristics

 Age at giving birth (years)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

 Parity (n)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

 Smoking during pregnancy

n (%)

n (%)

 Preterm premature rupture of the membranes

n (%)

n (%)

  - Gestational age at occurrence (weeks)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Any administration of antenatal corticosteroids

 Mode of delivery:

  - Vaginal birth

n (%)

n (%)

  - Caesarean section

n (%)

n (%)

 ◦ Indication:

  ▪ Elective

n (%)

n (%)

  ▪ Emergency

n (%)

n (%)

 • Reason:

  ◦ Fetal distress

n (%)

n (%)

  ◦ Failure to progress

n (%)

n (%)

  ◦ Maternal indication

n (%)

n (%)

 • Use of general anaesthetics

n (%)

n (%)

Fetal baseline characteristics

 Estimated severity of lung hypoplasia:

  - Mild

n (%)

n (%)

  - Moderate

n (%)

n (%)

  - Severe

n (%)

n (%)

 Liver position:

  - Intra-abdominal

n (%)

n (%)

  - Intrathoracic

n (%)

n (%)

 Observed to expected lung-to-head ratio (%)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

  - Gestational age at measurement (weeks)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

 Fetal lung volume right lung (ml)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

 Fetal lung volume left lung (ml)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

 Observed to expected fetal lung volume (%)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

  - Gestational age at measurement (weeks)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

 Fetoscopic endoluminal tracheal occlusion therapy

n (%)

n (%)

  - Duration of tracheal occlusion (days)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Neonatal baseline characteristics

 Sex:

  - Male

n (%)

n (%)

  - Female

n (%)

n (%)

Birth weight (g)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Gestational age at birth (weeks)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Apgar score at 1 min

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Apgar score at 5 min

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Umbilical artery pH

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Intubation in the delivery room

- Conventional mechanical ventilation

n (%)

n (%)

- High frequency oscillatory ventilation

n (%)

n (%)

◦ Mean airway pressure (cmH2O)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

◦ Frequency (Hz)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

◦ Amplitude (cmH2O)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Continuous positive airway pressure in the delivery room

n (%)

n (%)

High flow in the delivery room

n (%)

n (%)

Initial fraction of inspired oxygen (%)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Maximum fraction of inspired oxygen (%)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Maximum positive end-expiratory pressure (cmH2O)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Maximum peak inspiratory pressure (cmH2O)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Maximum flow (l/min)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Body temperature at admission to the intensive care unit (degrees Celsius)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

Haemoglobin level at admission to the intensive care unit (mmol/l)

Mean ± SD or median [IQR]

Mean ± SD or median [IQR]

  1. ICC,Immediate cord clamping, IQR Interquartile range, PBCC Physiological-based cord clamping