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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Nantes University Hospital
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00764179
First received: September 30, 2008
Last updated: February 4, 2013
Last verified: February 2013

September 30, 2008
February 4, 2013
March 2008
July 2015   (final data collection date for primary outcome measure)
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 [ Time Frame: at 2 years old ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764179 on ClinicalTrials.gov Archive Site
  • Leptine, glycemia/insulin and pro-insulin blood level [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ] [ Designated as safety issue: No ]
  • Plasmatic and urinary citrulline levels [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ] [ Designated as safety issue: No ]
  • Micro-albuminuria, creatinine, urea, sodium and potassium urine levels [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ] [ Designated as safety issue: No ]
  • Faecal floa, faecal calprotectine and other markers [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ] [ Designated as safety issue: No ]
  • Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size [ Time Frame: at age of 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")
Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Intra-uterine Growth Delay
  • 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)
  • Experimental: 1
    hyperproteinic milk
    Intervention: Other: milk enriched in proteins (2.15 g/100ml)
  • Active Comparator: 2
    Normoproteinic milk
    Intervention: Other: milk with normal protein concentration (1.45g/100ml)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
July 2015
July 2015   (final data collection date for primary outcome measure)

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)
Both
34 Weeks to 39 Weeks
No
Contact: Dominique DARMAUN, Professor +33 2 40 08 42 75 ddarmaun@chu-nantes.fr
France
 
NCT00764179
06/12-P
No
Professor Dominique DARMAUN, Nantes University Hospital
Nantes University Hospital
Not Provided
Study Director: Dominique DARMAUN, Professor Nantes Universitary Hospital
Principal Investigator: Dominique DARMAUN, Professor Nantes Universitary Hospital
Study Chair: Jean-Christophe ROZE, Professor Nantes Universitary Hospital
Study Chair: Clotilde DES ROBERT, Doctor Nantes Universitary Hospital
Study Chair: Umberto SIMEONI, Professor AP-HM, "Hôpital de la conception- Marseille"
Study Chair: Régis HANKARD, Professor CHU of Poitiers
Study Chair: Eric DUMAS DE LA ROQUE, Doctor CHU of Bordeaux (Pellegrin-Tripode Hospital)
Study Chair: Olivier BAUD, Professor AP-HP (Paris - Robert Debré Hospital)
Nantes University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP