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Table 2 List of secondary outcomes, including the levels of measurement

From: Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

 

Unit of measurement

Categorial

Additional

Maternal and placental variables

 Estimated total blood loss

mL

  

 Postpartum hemorrhage > 1000 mL

 

Yes/No

 

 Rupture of umbilical cord

 

Yes/No

 

 Placental weight

Gram

  

 Surgical site infection after caesarean section

 

Yes/No

 

Variables related to stabilization at birth

 Support during transition

 

Yes/No

 

 Use of supplemental oxygen

 

Yes/No

 

 Use of continuous positive airway pressure

 

Yes/No

 

 Use of positive pressure ventilation

 

Yes/No

 

 Use of endotracheal ventilation

 

Yes/No

 

 Use of chest compressions

 

Yes/No

 

 Use of epinephrin

 

Yes/No

 

 Number of lung inflations

  

Total number

 Number of sustained inflation

  

Total number

 Maximum FiO2 administered

  

Fraction

 Apgar scores at 1, 5, and 10 min

 

1–10

 

 Time to stabilization

Minutes and seconds

  

 Cord clamping time

Minutes and seconds

  

 Arterial umbilical cord pH

   

Infant variables

 Temperature at admission

Degrees Celsius

  

 Hemoglobin (< 24 h)

mmol/L

  

 Hematocrit

L/L

  

 Polycythemia (venous hematocrit > 0.65 l/l)

 

Yes/No

 

 Intubation (< 72 h)

 

Yes/No

 

 Respiratory distress syndrome

 

Yes/No

 

 Surfactant therapy

 

Yes/No

 

 Pneumothorax

 

Yes/No

 

 Pulmonary hemorrhage

 

Yes/No

 

 Pulmonary interstitial emphysema

 

Yes/No

 

 Oxygen requirement (> 21%)

Days

  

 Bronchopulmonary dysplasia [6, 7]

 

Yes/No

Stage

 Volume expansion (< 72 h)

 

Yes/No

 

 Inotropic use (< 72 h)

 

Yes/No

 

 Persistent ductus arteriosus requiring treatment

 

Yes/No

Treatment

 Highest bilirubin level

μmol/l

  

 Hyperbilirubinemia requiring therapy

 

Yes/No

Treatment

 Culture-proven early-onset sepsis

 

Yes/No

 

 Culture-proven late-onset sepsis

 

Yes/No

Total number

 Meningitis

 

Yes/No

 

 Necrotizing enterocolitis [8]

 

Yes/No

Stage, treatment

 Focal intestinal perforation

 

Yes/No

 

 Red blood cell transfusion

 

Yes/No

Total number

 Intraventricular hemorrhage [9]

 

Yes/No

Stage

 Post-hemorrhagic ventricular dilatation

 

Yes/No

Treatment

 Periventricular venous infarction [9]

 

Yes/No

 

 Periventricular leukomalacia [10]

 

Yes/No

Stage

 Cerebellar hemorrhage

 

Yes/No

 

 Seizures

 

Yes/No

 

 Retinopathy of prematurity [11]

 

Yes/No

Stage, treatment

 Retinopathy of prematurity plus disease [11]

 

Yes/No

 

 Mortality at 28 days postnatal age

 

Yes/No

 

 Mortality at 36 weeks PMA

 

Yes/No

 

 Mortality at hospital discharge

 

Yes/No

 

 Length of NICU stay

Days

  

 Length of hospital stay

Days

  

 Weight, length, and head circumference at discharge

Gram, cm

  
  1. FiO2 Fraction of inspired oxygen, PMA Post-menstrual age, NICU Neonatal intensive care unit