Intra-uterine Growth DelayProneonatNCT00764179
Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")
A study testing milk enriched in proteins (2.15 g/100ml) and milk with normal protein concentration (1.45g/100ml) in people with Intra-uterine Growth Delay, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 to 39 weeks
- Conditions the study is for
- Intra-uterine Growth Delay
- What is being tested?
- milk enriched in proteins (2.15 g/100ml) and milk with normal protein concentration (1.45g/100ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 39 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Subject not fulfilling inclusion criteria
- Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Intra-uterine Growth Delay
- Being tested
- milk enriched in proteins (2.15 g/100ml), milk with normal protein concentration (1.45g/100ml)
- Keywords
- Neonates with intra-uterine growth delay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk enriched in proteins (2.15 g/100ml)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)
milk with normal protein concentration (1.45g/100ml)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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | hyperproteinic milk Receives: Other: milk enriched in proteins (2.15 g/100ml) |
| 2 | Active comparator | Normoproteinic milk Receives: Other: milk with normal protein concentration (1.45g/100ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2
Measured: at 2 years old
Secondary outcomes (5)
Leptine, glycemia/insulin and pro-insulin blood level
Measured: At age of 15 (+/- 2) days and at age of 2 years
Plasmatic and urinary citrulline levels
Measured: At age of 15 (+/- 2) days and at age of 2 years
Micro-albuminuria, creatinine, urea, sodium and potassium urine levels
Measured: At age of 15 (+/- 2) days and at age of 2 years
Faecal floa, faecal calprotectine and other markers
Measured: At age of 15 (+/- 2) days and at age of 2 years
Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size
Measured: at age of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: difficulties of recruitment, high number of patients lost to follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-uterine Growth DelayStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique DARMAUN, Professor, Study director, Nantes Universitary HospitalDominique DARMAUN, Professor, Principal investigator, Nantes Universitary HospitalJean-Christophe ROZE, Professor, Study chair, Nantes Universitary HospitalClotilde DES ROBERT, Doctor, Study chair, Nantes Universitary HospitalUmberto SIMEONI, Professor, Study chair, AP-HM, "Hôpital de la conception- Marseille"Régis HANKARD, Professor, Study chair, CHU of PoitiersEric DUMAS DE LA ROQUE, Doctor, Study chair, CHU of Bordeaux (Pellegrin-Tripode Hospital)Olivier BAUD, Professor, Study chair, AP-HP (Paris - Robert Debré Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764179
- Sponsor's protocol ID
- BRD/06/12-P
- Acronym
- Proneonat
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2008
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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")
- ClinicalTrials.gov ID
- NCT00764179
- Acronym / sponsor ID
- Proneonat / BRD/06/12-P
- Conditions
- Intra-uterine Growth Delay
- Keywords
- Neonates with intra-uterine growth delay
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties of recruitment, high number of patients lost to follow-up
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: milk enriched in proteins (2.15 g/100ml)hyperproteinic milk |
| 2 | Active comparator | Other: milk with normal protein concentration (1.45g/100ml)Normoproteinic milk |
Who may qualify
- Ages
- 34 to 39 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Subject not fulfilling inclusion criteria
- Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | 1 |
| 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) | Other | 2 |
Primary outcome
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2
Time frame: at 2 years old
5 secondary outcomes
Leptine, glycemia/insulin and pro-insulin blood level
Time frame: At age of 15 (+/- 2) days and at age of 2 years
Plasmatic and urinary citrulline levels
Time frame: At age of 15 (+/- 2) days and at age of 2 years
Micro-albuminuria, creatinine, urea, sodium and potassium urine levels
Time frame: At age of 15 (+/- 2) days and at age of 2 years
Faecal floa, faecal calprotectine and other markers
Time frame: At age of 15 (+/- 2) days and at age of 2 years
Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size
Time frame: at age of 2 years
Results and safety
The study was stopped early (reason given: difficulties of recruitment, high number of patients lost to follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique DARMAUN, Professor study director
Nantes Universitary Hospital
Dominique DARMAUN, Professor principal investigator
Nantes Universitary Hospital
Jean-Christophe ROZE, Professor study chair
Nantes Universitary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk enriched in proteins (2.15 g/100ml) and milk with normal protein concentration (1.45g/100ml) in people with Intra-uterine Growth Delay, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties of recruitment, high number of patients lost to follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2 (time frame: at 2 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.