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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Intra-uterine Growth Delay

Treatments: Other: milk enriched in proteins (2.15 g/100ml); Other: milk with normal protein concentration (1.45g/100ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT00764179

BRD/06/12-P

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 34 to 39 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 2 patient groups

1

Experimental group

Description:

hyperproteinic milk

Treatment:

Other: milk enriched in proteins (2.15 g/100ml)

2

Active Comparator group

Description:

Normoproteinic milk

Treatment:

Other: milk with normal protein concentration (1.45g/100ml)