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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intra-uterine Growth Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

hyperproteinic milk

Group Type EXPERIMENTAL

milk enriched in proteins (2.15 g/100ml)

Intervention Type OTHER

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)

2

Normoproteinic milk

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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

* Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth)

Minimum Eligible Age

34 Weeks

Maximum Eligible Age

39 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No