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Table 2 Primary and secondary outcomes

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)

p value

Differencea

Relative riskb

Primary outcome

 Pulmonary hypertension (defined as at least 2 out of 4 criteria for pulmonary hypertension or need for ECMO therapy in the first 24 h) after birth in the total study population

n (%)

n (%)

p

Difference (95% CI)

RR (95% CI)

 Pulmonary hypertension or need for ECMO therapy in the first 24 h after birth in subgroups with estimated:

  - Mild pulmonary hypoplasia

n (%)

n (%)

p

Difference (95% CI)

RR (95% CI)

  - Moderate pulmonary hypoplasia

n (%)

n (%)

p

Difference (95% CI)

RR (95% CI)

  - Severe pulmonary hypoplasia

n (%)

n (%)

p

Difference (95% CI)

RR (95% CI)

Secondary outcomesc

 Mortality before discharge from tertiary care hospital

n (%)

n (%)

 

Difference (95% CI)

RR (95% CI)

 Presence of ≥ 3 criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 h after birth

n (%)

n (%)

 

Difference (95% CI)

RR (95% CI)

 ECMO therapy

n (%)

n (%)

 

Difference (95% CI)

RR (95% CI)

 Number of days needing supplemental oxygen

Mean ± SD and median [IQR]

Mean ± SD and median [IQR]

 

Difference (95% CI)

 

 Number of days on mechanical ventilation

Mean ± SD and median [IQR]

Mean ± SD and median [IQR]

 

Difference (95% CI)

 

 Number of days of admission to tertiary care hospital

Mean ± SD and median [IQR]

Mean ± SD and median [IQR]

 

Difference (95% I)

 

 Postpartum haemorrhage (estimated maternal blood loss > 1000 ml)

n (%)

n (%)

 

Difference (95% CI)

RR (95% CI)

  1. CI Confidence interval, ECMO Extracorporeal membrane oxygenation, ICC Immediate cord clamping, IQR Interquartile range, OR Odds ratio, PBCC Physiological-based cord clamping, RR Relative risk, SD Standard deviation
  2. aDifferences will be calculated as the absolute difference in percentages for dichotomous data or as the difference in medians and means for continuous data
  3. bRelative risks will only be calculated for dichotomous data
  4. cSecondary outcomes will be reported in the total study population and in the subgroup with survivors, respectively