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

Not Applicable

Terminated

• Conditions: Intra-uterine Growth Delay
• Interventions: Other: milk with normal protein concentration (1.45g/100ml); Other: milk enriched in proteins (2.15 g/100ml)

• Registration Number: NCT00764179
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	milk with normal protein concentration (1.45g/100ml)	Normoproteinic milk
1	milk enriched in proteins (2.15 g/100ml)	hyperproteinic milk

Primary Outcome Measures

Name	Time	Method
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2	at 2 years old

Secondary Outcome Measures

Name	Time	Method
Plasmatic and urinary citrulline levels	At age of 15 (+/- 2) days and at age of 2 years
Leptine, glycemia/insulin and pro-insulin blood level	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

Trial Locations

Locations (1)

Universitary Hospital; 🇫🇷 Nantes, France