Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")

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.

Conditions

• Intra-uterine Growth Delay

Interventions

OTHER

milk 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)

OTHER

milk 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 & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Dominique DARMAUN, Professor · Nantes Universitary Hospital

• Dominique DARMAUN, Professor · Nantes Universitary Hospital

• Jean-Christophe ROZE, Professor · Nantes Universitary Hospital

• Clotilde DES ROBERT, Doctor · Nantes Universitary Hospital

• Umberto SIMEONI, Professor · AP-HM, "Hôpital de la conception- Marseille"

• Régis HANKARD, Professor · CHU of Poitiers

• Eric DUMAS DE LA ROQUE, Doctor · CHU of Bordeaux (Pellegrin-Tripode Hospital)

• Olivier BAUD, Professor · AP-HP (Paris - Robert Debré Hospital)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

34 Weeks

Max Age

39 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• France

Study Locations