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.
Verified February 2013 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00764179
First received: September 30, 2008
Last updated: February 4, 2013
Last verified: February 2013
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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
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 June 18, 2013