Intra-uterine Growth Delay
Conditions
Keywords
Neonates with intra-uterine growth delay
Brief summary
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.
Interventions
OTHERmilk enriched in proteins (2.15 g/100ml)
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)
OTHERmilk with normal protein concentration (1.45g/100ml)
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)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
34 Weeks to 39 Weeks
Healthy volunteers
No
Inclusion criteria
* Neonates with intra-uterine growth delay (with weight \< 10th centile) * Aged \>34 weeks of amenorrhoea * For neonates \>38 weeks of amenorrhoea, weight \< 2500g * Mother's refusal of breast feeding * Informed consent signed by the 2 parents * Possibility to follow newborns until age of 2
Exclusion criteria
* Subject not fulfilling inclusion criteria * Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 | at 2 years old |
Secondary
| Measure | 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 |
| 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 |
Countries
France
Outcome results
None listed