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This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.
When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Formula | Active Comparator | Standard formula for preterm infants. |
|
| Experimental formula | Experimental | Formula with higher protein and new fat blend for preterm infants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard formula for preterm infants | Other | Reconstituted in water and given to infants at more than 50% of feedings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth in terms of weight gain per day | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Growth in terms of length and head circumference | Till infant reaches 3kg (study completion), expected within 3 months | |
| Feeding tolerance (frequency of regurgitation, stool frequency and consistency) | Till infant reaches 3kg (study completion), expected within 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Tan | Société des Produits Nestlé (SPN) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tu Du Hospital | Ho Chi Minh City | Ho Chi Minh | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35000893 | Derived | Thanh LQ, Chen Y, Hartweg M, Thi Nguyen TA. Effects of higher protein formula with improved fat blend on growth, feeding tolerance and nutritional biomarkers in preterm infants: A double-blind, randomized, controlled clinical trial. Pediatr Neonatol. 2022 May;63(3):227-238. doi: 10.1016/j.pedneo.2021.09.007. Epub 2021 Dec 4. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005526 | Food, Formulated |
| ID | Term |
|---|---|
| D019648 | Foods, Specialized |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Formula with higher protein and new fat blend for preterm infants | Other | Reconstituted in water and given to infants at more than 50% of feedings. |
|
| Incidence of adverse events | 30 days post infant stopping study infant formula intake upon reaching 3kg |
| D000091642 | Urogenital Diseases |
| D019602 |
| Food and Beverages |