Clinical trial NCT00764179: Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")
Official title: Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intra-uterine Growth Delay
Keywords: Neonates with intra-uterine growth delay
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 93
Sex: ALL
Minimum age (years): 34
Maximum age (years): 39
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2
timeFrame: at 2 years old
Secondary outcomes:
measure: Leptine, glycemia/insulin and pro-insulin blood level
timeFrame: At age of 15 (+/- 2) days and at age of 2 years
measure: Plasmatic and urinary citrulline levels
timeFrame: At age of 15 (+/- 2) days and at age of 2 years
measure: Micro-albuminuria, creatinine, urea, sodium and potassium urine levels
timeFrame: At age of 15 (+/- 2) days and at age of 2 years
measure: Faecal floa, faecal calprotectine and other markers
timeFrame: At age of 15 (+/- 2) days and at age of 2 years
measure: Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size
timeFrame: at age of 2 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Universitary Hospital
Study officials:
affiliation: Nantes Universitary Hospital
name: Dominique DARMAUN, Professor
role: STUDY_DIRECTOR
affiliation: Nantes Universitary Hospital
name: Dominique DARMAUN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes Universitary Hospital
name: Jean-Christophe ROZE, Professor
role: STUDY_CHAIR
affiliation: Nantes Universitary Hospital
name: Clotilde DES ROBERT, Doctor
role: STUDY_CHAIR
affiliation: AP-HM, "Hôpital de la conception- Marseille"
name: Umberto SIMEONI, Professor
role: STUDY_CHAIR
affiliation: CHU of Poitiers
name: Régis HANKARD, Professor
role: STUDY_CHAIR
affiliation: CHU of Bordeaux (Pellegrin-Tripode Hospital)
name: Eric DUMAS DE LA ROQUE, Doctor
role: STUDY_CHAIR
affiliation: AP-HP (Paris - Robert Debré Hospital)
name: Olivier BAUD, Professor
role: STUDY_CHAIR
References: