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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2	at 2 years old

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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)

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Neonates with intra-uterine growth delay
• Other Study ID Numbers: BRD/06/12-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No