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

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ClinicalTrials.gov Identifier: NCT00764179
Recruitment Status : Terminated (difficulties of recruitment, high number of patients lost to follow-up)
First Posted : October 1, 2008
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intra-uterine Growth Delay Other: milk enriched in proteins (2.15 g/100ml) Other: milk with normal protein concentration (1.45g/100ml) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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")
Study Start Date : March 2008
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 [ Time Frame: at 2 years old ]

Secondary Outcome Measures :
  1. Leptine, glycemia/insulin and pro-insulin blood level [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ]
  2. Plasmatic and urinary citrulline levels [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ]
  3. Micro-albuminuria, creatinine, urea, sodium and potassium urine levels [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ]
  4. Faecal floa, faecal calprotectine and other markers [ Time Frame: At age of 15 (+/- 2) days and at age of 2 years ]
  5. Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size [ Time Frame: at age of 2 years ]


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Ages Eligible for Study:   34 Weeks to 39 Weeks   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764179


Locations
France
Universitary Hospital
Nantes, France, 44093
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)

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00764179     History of Changes
Other Study ID Numbers: BRD/06/12-P
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

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