Table 2

Distribution of Study Variables in the Population and Study Samples by Intervention Group

Variable

Control Group

Intervention Group


Population

Total Sample

Sub-sample with Mortality Outcome

Population

Total Sample

Sub-sample with Mortality Outcome


Overall Sample Size

499

456

441

707

663

602

Maternal Age

25.78 (6.89)

25.77 (6.94)

25.79 (6.89)

26.37 (6.92)

26.30 (6.86)

26.29 (6.86)

Number of prenatal visits

5.58 (3.01)

5.65 (2.95)

5.66 (2.94)

4.51 (3.51)

4.56 (3.51)

4.67 (3.51)

Maternal chronic illness (N)

469

431

419

702

659

598

No (%)

395(84.2)

358 (83.1)

347 (82.8)

548 (78.1)

516 (78.3)

471 (78.8)

Yes (%)

74(15.8)

73 (16.9)

72 (17.2)

154 (21.9)

143 (21.7)

127 (21.2)

Ethnic Ancestry (N)

465

427

416

691

652

592

Black (%)

51(11.0)

51 (11.9)

50 (12.0)

81 (11.7)

77 (11.8)

68 (11.5)

Native (%)

348(74.8)

313 (73.3)

303 (72.8)

523 (75.7)

492 (75.5)

449 (75.8)

Other (%)

66(14.2)

63 (14.8)

63 (15.1)

87 (12.6)

83 (12.7)

75 (12.7)

Birth weight (grams)

2887.5 (788.5)

2,863.5 (797.8)

2870.8 (803.7)

2881.9 (740.3)

2,892.9(726.7)

2871.3 (732.2)

Gestational age (weeks)

38.3 (3.4)

38.3 (3.4)

38.3 (3.5)

38.5 (3.1)

38.5 (3.1)

38.4 (3.2)

Time of cleft diagnosis (N)

495

454

439

701

657

596

Prenatal (%)

80 (16.2)

76 (16.7)

73 (16.6)

174 (24.8)

161 (24.5)

145 (24.3)

Other (%)

415(83.8)

378 (83.3)

366 (83.4)

527 (75.2)

496 (75.5)

451 (75.7)

Sex (N)

491

450

437

705

661

601

Male (%)

275(56.0)

250 (55.6)

245 (56.1)

394 (55.9)

372 (56.3)

338 (56.2)

Female (%)

216(44.0)

200 (44.4)

192 (43.9)

311 (44.1)

289 (43.7)

263 (43.8)

Multiple birth (N)

496

455

440

707

663

602

No (%)

484(97.6)

443 (97.4)

428 (97.3)

688 (97.3)

646 (97.4)

586 (97.3)

Yes (%)

12 (2.4)

12 ( 2.6)

12 (2.7)

19 (2.7)

17 ( 2.6)

16 (2.7)

Associated Status (N)

499

456

441

707

663

602

Isolated (%)

361(72.3)

325 (71.3)

313 (71.0)

478 (67.6)

451 (68.0)

405 (67.3)

Associated (%)

138(27.7)

131 (28.7)

128 (29.0)

229 (32.4)

212 (32.0)

197 (32.7)

Type of Cleft (N)

496

455

441

706

663

602

Palate only (%)

129(26.0)

121 (26.6)

118 (26.8)

197(27.9)

181 (27.3)

163 (27.1)

Lip only (%)

87(17.5)

77 (16.9)

75 (17.0)

120(17.0)

111 (16.7)

101 (16.8)

Lip and Palate (%)

280(56.5)

257 (56.5)

248 (56.2)

389(55.1)

371 (56.0)

338 (56.2)

Type of Delivery (N)

492

451

436

707

663

602

Cesarean (%)

184(37.4)

168 (37.3)

163 (37.4)

280(39.6)

258 (38.9)

238 (39.5)

Other (%)

308 (62.6)

283 (62.7)

273 (62.6)

427 (60.4)

405 (61.1)

364 (60.5)


The Table includes the distribution of study variables in the study population, study sample and sample with mortality data. Means and standard deviations (in parentheses) are reported for continuous variables. Counts and percentages (in parentheses) are reported for categorical variables.

The following comparisons were examined within each of the intervention and control groups: 1) population versus study sample and 2) study sample versus sample with mortality data.

The differences in the number of observations in the subsamples with mortality outcome in this table and those included in mortality analysis in Table 1 is due to limiting the mortality analysis to those who were alive on the 7th day after birth. The subsamples with mortality outcome in Table 6 include all consented infants with known mortality outcome including those who died before the 7th day of life since the goal is to check for any characteristics that are related to dropping out of the study resulting in unknown mortality status.

Wehby et al. BMC Pediatrics 2011 11:121   doi:10.1186/1471-2431-11-121

Open Data