International Journal of Pediatrics

Research Article

A Pooled Analysis of Growth and Tolerance of Infants Exclusively Fed Partially Hydrolyzed Whey or Intact Protein-Based Infant Formulas

Table 2

Adjusted percentages (95% CIs) of stool consistency at 1, 2, 3, and 4 months, by formula group based on a pooled analysis of individual data from four Nestlé PHF-W (Good Start) growth studies and 3 Nestlé CMF (Nan) growth studies.


Age	Consistency Category	Actual Pooled Percentage of Stool Consistency ()		Adjusted Percentage of Stool Consistency and 95% CI ()		p-value
		CMF	PHF-W	CMF	PHF-W

1 month	Liquid	4%	7%	4.1% (2.2, 6.1)	6.6% (4.5, 8.8)	0.073
	Soft	49%	79%	48.9% (45.6, 52.2)	81.1% (78.6, 83.5)	<0.001
	Formed	31%	11%	36.7% (33.6, 39.9)	11.1% (9.5, 12.6)	<0.001
	Hard	11%	1%	10.2% (8.1, 12.3)	1.2% (0.6, 1.7)	<0.001

2 months	Liquid	4%	5%	4.5% (2.6, 6.4)	7.8% (5.5, 10.0)	0.022
	Soft	44%	80%	52.0% (49.6, 54.4)	80.2% (77.9, 82.4)	<0.001
	Formed	42%	11%	37.4% (35.2, 39.6)	11.2% (10.2, 12.3)	<0.001
	Hard	4%	1%	6.1% (5.1, 7.2)	0.8% (0.5, 1.1)	<0.001

3 months	Liquid	5%	8%	4.8% (6.5, 11.6)	9.1% (6.5, 11.6)	0.007
	Soft	48%	78%	54.2% (51.6, 56.8)	79.0% (76.5, 81.5)	<0.001
	Formed	36%	11%	37.4% (34.9, 39.8)	11.4% (10.2, 12.6)	<0.001
	Hard	3%	1%	3.6% (2.6, 4.6)	0.5% (0.2, 0.8)	<0.001

4 months	Liquid	4%	10%	5.1% (2.7, 7.5)	10.5% (7.5, 13.6)	0.005
	Soft	56%	76%	55.9% (52.0, 59.7)	77.6% (74.4, 80.8)	<0.001
	Formed	31%	12%	36.9% (33.3, 40.6)	11.5% (9.6, 13.3)	<0.001
	Hard	3%	<1%	2.1% (1.2, 3.0)	0.4% (0.1, 0.7)	<0.001

Adjusted percentages are rescaled marginal probabilities of stool consistency obtained from a longitudinal multinomial regression model with adjustment for treatment, age and treatment-by-age interaction, and accounting for clustering within study and infant. P-values are based on comparisons of the marginal probability of stool consistency at each time point. Based on the number of multiple comparisons made, a p-value of <0.003 is considered statistically significant. Actual (unadjusted) pooled percentages are also presented here; some stools were reported but missing consistency categorization.