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
  Purpose

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.


Condition Intervention
Intra-uterine Growth Delay
Other: milk enriched in proteins (2.15 g/100ml)
Other: milk with normal protein concentration (1.45g/100ml)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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")

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 126
Study Start Date: March 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
hyperproteinic milk
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)
Active Comparator: 2
Normoproteinic milk
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)

  Eligibility

Ages Eligible for Study:   34 Weeks to 39 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764179

Contacts
Contact: Dominique DARMAUN, Professor +33 2 40 08 42 75 ddarmaun@chu-nantes.fr

Locations
France
Universitary Hospital Recruiting
Nantes, France, 44093
Contact: Dominique DARMAUN, Professor    +33 2 40 08 42 75    ddarmaun@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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)
  More Information

No publications provided

Responsible Party: Professor Dominique DARMAUN, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00764179     History of Changes
Other Study ID Numbers: 06/12-P
Study First Received: September 30, 2008
Last Updated: February 4, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by Nantes University Hospital:
Neonates with intra-uterine growth delay

ClinicalTrials.gov processed this record on August 21, 2014