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difficulties of recruitment, high number of patients lost to follow-up
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Neonates with intra-uterine growth delay represent more than 2% of the 800 000 annual births in France. Studies have shown that milks enriched with protein allow to accelerate newborns growth. According to some papers, growth acceleration would have a favourable effect on psycho-motor development at age of 2 or 3. However, for other authors, this would not lead to any benefit and even an early hyperproteinic feeding would have bad long term consequences such as appearance of several diseases in the future adult (overweight, diabetes, arterial hypertension, renal function alteration).The main objective of this clinical trial is to check that an hyperproteinic feeding does not lead to any benefit on psycho-motor development at age of 2, compared with a milk containing same level of protein than milk proposed to newborns of normal weight. The secondary objectives of our clinical trial are to compare the effects of these two types of milk on renal function, arterial blood pressure, body composition, corpulence, food preferences, insulin resistance and intestinal integrity at age of 2. A sub study will also be realized to analyse the proteic turn over . This sub-study will be undertaken only with neonates of Nantes Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | hyperproteinic milk |
|
| 2 | Active Comparator | Normoproteinic milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milk enriched in proteins (2.15 g/100ml) | Other | Neonates will drink the hyperproteinic milk until they reach the 25th of "Sempé and Pedron" curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age) |
| Measure | Description | Time Frame |
|---|---|---|
| Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 | at 2 years old |
| Measure | Description | Time Frame |
|---|---|---|
| Leptine, glycemia/insulin and pro-insulin blood level | At age of 15 (+/- 2) days and at age of 2 years | |
| Plasmatic and urinary citrulline levels | At age of 15 (+/- 2) days and at age of 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique DARMAUN, Professor | Nantes Universitary Hospital | Study Director |
| Dominique DARMAUN, Professor | Nantes Universitary Hospital | Principal Investigator |
| Jean-Christophe ROZE, Professor | Nantes Universitary Hospital | Study Chair |
| Clotilde DES ROBERT, Doctor | Nantes Universitary Hospital | Study Chair |
| Umberto SIMEONI, Professor | AP-HM, "HĂ´pital de la conception- Marseille" | Study Chair |
| RĂ©gis HANKARD, Professor | CHU of Poitiers | Study Chair |
| Eric DUMAS DE LA ROQUE, Doctor | CHU of Bordeaux (Pellegrin-Tripode Hospital) | Study Chair |
| Olivier BAUD, Professor | AP-HP (Paris - Robert Debré Hospital) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary Hospital | Nantes | 44093 | France |
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| milk with normal protein concentration (1.45g/100ml) | Other | Neonates will drink the normoproteinic milk until they reach the 25th of "Sempé and Pedron" curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age) |
|
| Micro-albuminuria, creatinine, urea, sodium and potassium urine levels |
| At age of 15 (+/- 2) days and at age of 2 years |
| Faecal floa, faecal calprotectine and other markers | At age of 15 (+/- 2) days and at age of 2 years |
| Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size | at age of 2 years |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D008892 | Milk |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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