Intra-uterine Growth Delay Clinical Trial
— ProneonatOfficial title:
Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")
| Verified date | October 2016 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Direction Générale de la Santé |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 93 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 34 Weeks to 39 Weeks |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Universitary Hospital | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 | at 2 years old | No | |
| Secondary | Leptine, glycemia/insulin and pro-insulin blood level | At age of 15 (+/- 2) days and at age of 2 years | No | |
| Secondary | Plasmatic and urinary citrulline levels | At age of 15 (+/- 2) days and at age of 2 years | No | |
| Secondary | Micro-albuminuria, creatinine, urea, sodium and potassium urine levels | At age of 15 (+/- 2) days and at age of 2 years | No | |
| Secondary | Faecal floa, faecal calprotectine and other markers | At age of 15 (+/- 2) days and at age of 2 years | No | |
| Secondary | Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size | at age of 2 years | No |