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Table 3 Baseline characteristics and clinical genetics

From: A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

 

6 months surgery

12 months surgery

Overall

Number of patients

XX

XX

XX

Baseline characteristics

 Gender

N

XX

XX

XX

 Male; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

 Female; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Not known; n

XX

XX

XX

 Gestational age (weeks)

N

XX

XX

XX

Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

(Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

Not known; n

XX

XX

XX

 Size of cleft

N

XX

XX

XX

Soft palate only; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Soft and hard palate; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Not known; n

XX

XX

XX

Clinical genetics

 Ethnicity

White; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Black; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Asian; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Chinese; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Mixed; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Other; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Not stated; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Not known; n

XX

XX

XX

 Weight at examination (grammes)

N

XX

XX

XX

Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

(Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

Not known; n

XX

XX

XX

 Length at examination (cm)

N

XX

XX

XX

Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

(Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

Not known; n

XX

XX

XX

 Occipitofrontal circumference (cm)

N

XX

XX

XX

Mean (SD)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

Median (IQR)

XX.X (XX.X)

XX.X (XX.X)

XX.X (XX.X)

(Min, max)

(XX.X, XX.X)

(XX.X, XX.X)

(XX.X, XX.X)

Not known; n

XX

XX

XX

 Interpretation of DENVER-II

Normal; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Suspect; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Un-testable; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Not known; n

XX

XX

XX

 Diagnosis

Known syndrome; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Unknown syndrome; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Severe developmental delay; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Uncertain; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Non-syndromic; n (%)

XX (XX.X)

XX (XX.X)

XX (XX.X)

Not known; n

XX

XX

XX