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The primary objective of the study was to compare the growth parameters of children approximately 2* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.
(* The mean age of subjects was 33.0 months due to a delay in the study start-up.)
This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Control: Children who had received Standard formula (SF) as infants | ||
| Experimental | Experimental: Children who had received lower protein formula as infants |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-Length Z-Scores | Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts. | 2 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-age Z-score | Weight-for-age Z-score based on World Health Organization (WHO) growth charts | 2 years of age |
| Length-for-age Z-score | Length-for-age Z-score based on World Health Organization (WHO) growth charts |
| Measure | Description | Time Frame |
|---|---|---|
| Stool microbiota Follow-up Study of Growth at 2 Years of Age | Stool microbiota included relative abundance of the following classes of bacteria, expressed as a percentage of total bacteria:
| 2 years of age |
| Stool composition |
Inclusion Criteria:
Exclusion Criteria:
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Children 2 years of age who were enrolled in the Wyeth Nutrition study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Hospital and Medical Center | Filinvest Corporate City, Alabang, | Muntinlupa City | 1780 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929831 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2. |
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| ID | Term |
|---|---|
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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stool
| 2 years of age |
| Head circumference-for-age Z-score | Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts | 2 years of age |
| BMI-for-age Z-score | BMI-for-age Z-score based on WHO and Centers for Disease Control (CDC) growth charts | 2 years of age |
| Dietary intake | Dietary intake (servings per day), percent contribution to energy intake, and percent contribution to protein intake of Dietary endpoints included mean intake (servings per day), percentage contribution to energy intake, and percentage contribution to protein intake of:
| 2 years of age |
| Nutrient intake | Nutrition endpoints included mean intake and percentage adequacy based on the recommended intake of:
| 2 years of age |
quantitative measures of the following parameters in stool wet and dry weight:
|
| 2 years of age |
| Incidence of adverse events | Safety was evaluated from signing of the informed consent to study completion, through the recording and monitoring of adverse events. | 2 years of age |