## Protocol Section
### Identification Module
**NCT ID:** NCT00764179

**Acronym:** Proneonat

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

**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")

#### Organization Study ID Info
**ID:** BRD/06/12-P
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-10-04

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Start Date
**Date:** 2008-03

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2008-10-01
**Type:** ESTIMATED
**Study First Submit Date:** 2008-09-30
**Study First Submit QC Date:** 2008-09-30
**Why Stopped:** difficulties of recruitment, high number of patients lost to follow-up
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nantes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Intra-uterine Growth Delay

**Keywords:**

- Neonates with intra-uterine growth delay

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 93

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** hyperproteinic milk

**Intervention Names:**

- Other: milk enriched in proteins (2.15 g/100ml)

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Normoproteinic milk

**Intervention Names:**

- Other: milk with normal protein concentration (1.45g/100ml)

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 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)

**Name:** milk enriched in proteins (2.15 g/100ml)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** 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)

**Name:** milk with normal protein concentration (1.45g/100ml)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2

**Time Frame:** at 2 years old

#### Secondary Outcomes

**Measure:** Leptine, glycemia/insulin and pro-insulin blood level

**Time Frame:** At age of 15 (+/- 2) days and at age of 2 years

**Measure:** Plasmatic and urinary citrulline levels

**Time Frame:** At age of 15 (+/- 2) days and at age of 2 years

**Measure:** Micro-albuminuria, creatinine, urea, sodium and potassium urine levels

**Time Frame:** At age of 15 (+/- 2) days and at age of 2 years

**Measure:** Faecal floa, faecal calprotectine and other markers

**Time Frame:** At age of 15 (+/- 2) days and at age of 2 years

**Measure:** Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size

**Time Frame:** at age of 2 years

### Eligibility Module

**Eligibility 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)

**Maximum Age:** 39 Weeks

**Minimum Age:** 34 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nantes

**Country:** France

**Facility:** Universitary Hospital

**Zip:** 44093

#### Overall Officials

**Official 1:**

**Affiliation:** Nantes Universitary Hospital

**Name:** Dominique DARMAUN, Professor

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Nantes Universitary Hospital

**Name:** Dominique DARMAUN, Professor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Nantes Universitary Hospital

**Name:** Jean-Christophe ROZE, Professor

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Nantes Universitary Hospital

**Name:** Clotilde DES ROBERT, Doctor

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** AP-HM, "Hôpital de la conception- Marseille"

**Name:** Umberto SIMEONI, Professor

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** CHU of Poitiers

**Name:** Régis HANKARD, Professor

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** CHU of Bordeaux (Pellegrin-Tripode Hospital)

**Name:** Eric DUMAS DE LA ROQUE, Doctor

**Role:** STUDY_CHAIR

**Official 8:**

**Affiliation:** AP-HP (Paris - Robert Debré Hospital)

**Name:** Olivier BAUD, Professor

**Role:** STUDY_CHAIR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
