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Table 1 Baseline characteristics at time of randomisation

From: The SHINE trial (a multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation): statistical analysis plan

Characteristic

Nasal HF group (n = XXX)

Control group (n = XXX)

Mothers

 Mode of delivery—no. (%)

  Vaginal delivery

XX (%)

XX (%)

  Caesarean section under spinal anaesthesia

XX (%)

XX (%)

  Caesarean section under general anaesthesia

XX (%)

XX (%)

Infants

 Gestational age at birth—weeks

Mean (SD)

Mean (SD)

  ≤ 28 weeks

XX (%)

XX (%)

  > 28 weeks

XX (%)

XX (%)

 Birth weight—grams

Mean (SD)

Mean (SD)

 Age at randomisation—hours

Mean (SD)

Mean (SD)

 Corrected GA at randomisation—weeks

Mean (SD)

Mean (SD)

 Weight at randomisation—grams

Mean (SD)

Mean (SD)

 Male—no. (%)

XX (%)

XX (%)

 Multiple birth—no. (%)

XX (%)

XX (%)

 Apgar score at 5 min

Mean (SD)

Mean (SD)

 Respiratory support prior to randomisation

  Nasal high flow

XX (%)

XX (%)

  Continuous positive airway pressure

XX (%)

XX (%)

  Intermittent positive pressure ventilation (IPPV) (via face mask, does not include IPPV following premedication)

XX (%)

XX (%)

  IPPV via endotracheal tube

XX (%)

XX (%)

  Low flow oxygen

XX (%)

XX (%)

  No respiratory support

XX (%)

XX (%)

 Fraction of inspired oxygen prior to randomisation

Mean (SD)

Mean (SD)

Intubation characteristic

 Primary reason for intubation—no. (%)

  Hypoxia

XX (%)

XX (%)

  Hypercarbia

XX (%)

XX (%)

  Apnoea

XX (%)

XX (%)

  Resuscitation

XX (%)

XX (%)

  Other

XX (%)

XX (%)

 Use of premedication—no. (%)

  Premedication

XX (%)

XX (%)

  No premedication

XX (%)

XX (%)

 First intubation attempt operator—no. (%)

  Resident/registrar/neonatal nurse practitioner

XX (%)

XX (%)

  Fellow/consultant

XX (%)

XX (%)

 Experience of operator (number of previous intubations)—no. (%)

   < 20 previous intubations

XX (%)

XX (%)

   ≥ 20 previous intubations

XX (%)

XX (%)

  1. N.B. Baseline demographic characteristics are for all intubation episodes