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In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.
Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.
After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high protein preterm infant formula | Experimental | preterm infant formula with high protein levels |
|
| control preterm formula | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preterm infant formula with high protein levels | Other | minimum 3 weeks feeding until hospital discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| comparison of weight gain between both study groups as a measure of safety | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of feeding tolerance and metabolic status between study groups as a measure of safety | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard J Cooke, MD | Department of Pediatrics St Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics St Louis University | St Louis | Missouri | 63104 | United States | ||
| Service Universitaire de Néonatologie CHR de la Citadelle |
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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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| preterm standard infant formula | Other | minimum 3 weeks feeding until hospital discharge |
|
| Liège |
| 4000 |
| Belgium |
| Service de néonatologie Hôpital de la Croix Rousse | Lyon | 69317 | France |
| Department of Child Health Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| D000091642 | Urogenital Diseases |