Other Preterm InfantsEPIPODNCT01450436
Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
An observational study of Other Preterm Infants, run by Nantes University Hospital at 1 site in France.
Trial summary
Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. Read more about this study
- Who is it for?
- Ages 25 to 35 weeks
- Conditions the study is for
- Other Preterm Infants
- What is being tested?
- Peapod assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Oct 2014
- Phase
- Observational
- 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 25 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (< 35 weeks gestation)
Who may be able to join
- Preterm newborns (< 35 weeks gestation).
- Final clinical discharge (No transfer)
- Oral Parental consent.
- Nantes NICU Neonatal management in the first 5 days of life
Who cannot join
- Congenital pathology inconsistent with PEAPOD investigation (Beckwith-Wiedemann syndrome, lipodystrophia with abnormal constitutional fat mass level).
- Pathology inducing neurodevelopment troubles.
- Transfer in an other hospital before discharge
- Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with PEAPOD measurement
Trial locations and contacts
1 site in 1 country.
About this study
Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and strategies have significantly evolved during these last years, influenced by Baker nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. In this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between heterogenous proteic input dispensed in our NICU (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. Understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.
- Conditions
- Other Preterm Infants
- Being tested
- Peapod assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peapod assessmentOther
EPIPOD consists in a Non-Interventional Research according to French regulations. Actually, Peapod examination at discharge takes part of current clinical practice and patient management in Nantes Neonatal Intensive Care Unit since 2008.
After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assessment at 2 years old).
| Study group | Role | What they receive |
|---|---|---|
| preterm infants (<35 weeks gestation) | Not described Receives: Other: Peapod assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty mass percentage at discharge by PEAPOD measurement
After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assesmment at 2 years old).
Measured: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)
Measured: ASQ/BLR Neurodevelopmental assesmment at 2 years old.
Secondary outcomes (5)
body composition of preterm infants at discharge and full term newborns at 3 days of life
Measured: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Relationship between body composition at discharge and that at 2 years
Measured: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Impact of fatty mass percentage at preterm newborns discharge on neurologic outcome assessed by a revised Brunet-Lezine test at 2 years.
Measured: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Preterm infants feeding behavior at 2 years
Measured: At 2 years old
Factors (both intrinsic and nutritional) influencing body composition of preterm infants (<35 weeks gestation), at discharge
Measured: factors influencing body composition report will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Preterm InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRONDAS-CHAUTY Anne, MD, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450436
- Sponsor's protocol ID
- PROG/11/80
- Acronym
- EPIPOD
- Status last verified
- Feb 2020
- First submitted
- 28 Sep 2011
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Roze JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.
PubMed 24808483
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
- ClinicalTrials.gov ID
- NCT01450436
- Acronym / sponsor ID
- EPIPOD / PROG/11/80
- Conditions
- Other Preterm Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Oct 2011 (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.
Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and strategies have significantly evolved during these last years, influenced by Baker nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. In this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between heterogenous proteic input dispensed in our NICU (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. Understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm infants (<35 weeks gestation) | – | Other: Peapod assessment |
Who may qualify
- Ages
- 25 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (< 35 weeks gestation)
Key inclusion criteria (4 listed)
- Preterm newborns (< 35 weeks gestation).
- Final clinical discharge (No transfer)
- Oral Parental consent.
- Nantes NICU Neonatal management in the first 5 days of life
Key exclusion criteria (4 listed)
- Congenital pathology inconsistent with PEAPOD investigation (Beckwith-Wiedemann syndrome, lipodystrophia with abnormal constitutional fat mass level).
- Pathology inducing neurodevelopment troubles.
- Transfer in an other hospital before discharge
- Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with PEAPOD measurement
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 |
|---|---|---|
| Peapod assessmentEPIPOD consists in a Non-Interventional Research according to French regulations. Actually, Peapod examination at discharge takes part of current clinical practice and patient management in Nantes Neonatal Intensive Care Unit since 2008. After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assessment at 2 years old). | Other | preterm infants (<35 weeks gestation) |
Primary outcome
Fatty mass percentage at discharge by PEAPOD measurement
Time frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assesmment at 2 years old).
Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)
Time frame: ASQ/BLR Neurodevelopmental assesmment at 2 years old.
5 secondary outcomes
body composition of preterm infants at discharge and full term newborns at 3 days of life
Time frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Relationship between body composition at discharge and that at 2 years
Time frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Impact of fatty mass percentage at preterm newborns discharge on neurologic outcome assessed by a revised Brunet-Lezine test at 2 years.
Time frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Preterm infants feeding behavior at 2 years
Time frame: At 2 years old
Factors (both intrinsic and nutritional) influencing body composition of preterm infants (<35 weeks gestation), at discharge
Time frame: factors influencing body composition report will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 24808483Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Roze JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
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.
FRONDAS-CHAUTY Anne, MD study director
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Preterm Infants, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Feb 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fatty mass percentage at discharge by PEAPOD measurement (time frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450436, which also lists 1 linked publication.
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 21 Feb 2020.