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The primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In addition the infants' digestive tolerance of the formulae and frequency of morbidity will be investigated.
The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 weeks old. Growth and other measurements will be collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life. Although the study intervention formally ends at 16 weeks, it will be useful to have a follow up visit at 26 weeks to collect further data on the gut microflora in the sub-group of infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of benefit to the subject as they receive a weight check and clinical examination by a paediatrician and will be offered to all subjects (no invasive procedures will be carried out).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard starter infant formula | Placebo Comparator | starter infant formula from enrollment till 16 weeks of age |
|
| starter infant formula with prebiotics | Experimental | starter infant formula from enrollment till 16 weeks of age |
|
| starter infant formula with pro and prebiotics | Experimental | starter infant formula from enrollment till 16 weeks of age |
|
| breastfeeding group | Other | exclusively breastfeeding during the first 16 weeks of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Other | infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean weight gain (g/day) | over 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| length (cm), head circumference (cm) | over 1 year | |
| • digestive tolerance (stool characteristics and frequency, vomiting, spitting up, frequency of colic) | over 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Ostetricia e Genecologia | Palermo | 90127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25527244 | Derived | Meli F, Puccio G, Cajozzo C, Ricottone GL, Pecquet S, Sprenger N, Steenhout P. Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial. BMC Pediatr. 2014 Dec 20;14:306. doi: 10.1186/s12887-014-0306-3. |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| D007774 | Lactation |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Breastfeeding | Other |
|
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |