Premature Birth of NewbornOPTIPREMANCT02686801
Body Composition at Discharge and Neurological Development at 2 Years in Very Preterm Infants (OPTIPREMA)
An observational study of Premature Birth of Newborn, run by Hôpital de la Croix-Rousse at 1 site in France.
Trial summary
This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development. Read more about this study
- Who is it for?
- Ages 1 week to 3 years
- Conditions the study is for
- Premature Birth of Newborn
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Dec 2019
- 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 1 week to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates
Who may be able to join
- Preterm newborns (less or equal to 32 weeks gestation and / or birthweight less or equal to1500g).
- Admitted in the Neonatal unit before day-of-life 7, staying at least 15 days in the unit, and discharged home at ≥ 35 weeks postconceptional age directly from the neonatal unit (no transfer)
- Oral Parental consent
Who cannot join
- Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with pediatric air-displacement plethysmography
- Pathology inducing neurodevelopment troubles
- Transfer in an other hospital before discharge
- Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with pediatric air-displacement plethysmography
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital de la croix rousse
Lyon, 69004
jean-charles picaud, MD, PhD, 0033472001550, jean-charles.picaud@chu-lyon.fr
About this study
Official title: Determinants of Body Composition at Discharge and Fat-Free Mass as an Indicator of Neurological Development at 2 Years in Very Preterm Infants : OPTIPREMA Study
This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development.
Read the detailed description
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Recent data from the literature show that it is possible - with appropriate nutritional care - to reduce the initial weight loss and to ensure that the growth deficit accumulated is then less important than was previously observed. The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (12-18 g/kg.day according to postconceptional age). Children often grow slowly during the first 10 days of life, so they accumulate a growth deficit that should be compensated secondarily. Therefore, optimum postnatal growth is 20 g/kg.day, rather than 15 g/kg.day. It is also important to assess the quality of growth, particularly fat free mass. The objective of nutritional care is dual: a sufficient weight gain (close to fetal growth rate) but also a relevant body composition. However, there is very little data on body composition of premature babies at discharge. It is now possible to measure quickly (one minute), simply and noninvasively using pediatric air-displacement plethysmography. Previous studies using more complex search techniques to implement (dual energy X-ray absorptiometry) showed excessive body fat at discharge in premature babies. Reference values collected using pediatric air-displacement plethysmography were published in 2011. Nutritional practices and strategies have significantly evolved in the past years to support such objectives: improvement of early parenteral nutrient intake, new fortifiers for human milk, new preterm formulas and early beginning of enteral nutrition. Individualized fortification of human milk helps to provide preterm infants with sufficient amount of nutrients. The modern nutritionnal care in preterm infants results in earlier and higher protein and energy intakes than previously performed. It improves some anthropometric parameters but little is know about body composition at discharge. Furthermore, exposition to high nutrients intake could lead to metabolic and hormonal imprinting with an increased risk of diabetes and cardio-vascular diseases in adulthood.
OPTIPREMA aim to focus the link between nutrient intakes during hospitalization, body composition at discharge and relationship between fat free mass variations at discharge and neurodevelopment at 2 years.
- Conditions
- Premature Birth of Newborn
- Keywords
- nutrition, prematurity, body composition
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat free mass at discharge
Fat-fee mass percentage at discharge by pediatric air-displacement plethysmography After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, pediatric air-displacement plethysmography is performed in the last week of hospitalization. Body composition estimation is completed by clinical and demographic data collection and collection of information about neonatal nutrition.
Measured: pediatric air-displacement plethysmography measurement will be done at 36 to 40 weeks postconceptional age
Secondary outcomes (6)
Factors (clinical characteristics at birth and morbidity, feeding regimen) influencing body composition at discharge
Factors (nutritional and others) influencing body composition of preterm infants (<35 weeks gestation) at discharge. Analysis will focuss on condotions that could be influenced by neonatal care, such as weight gain.
Measured: pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Prediction of fat free mass at discharge
Prediction of fat free mass at discharge from anthropometric data, nutritional intakes, and evolution during hospitalization.
Measured: pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Anthropometric parameters at discharge and at 2 years
Relationship between anthropometric parameters and body composition at discharge and growth at 2 years
Measured: measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age
Body mass index at discharge and at 2 years
Relationship betwen body mass index as an marker of body composition at discharge and growth at 2 years
Measured: measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age
Fat free mass in preterm infants fed human milk fortified in an individualized way
Impact of optimized feeding regimen using adjustable individualized fortification of human milk on fat free mass at discharge
Measured: pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Developmental score as measured by an appropriate neurodevelopmental test at 2 years
Children neurological development at 2 years old evaluated according to the follow-up routine evaluation or very low birth weight infants
Measured: Neurodevelopmental assessment at 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startApr 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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 Premature Birth of NewbornStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Croix-Rousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-charles PICAUD, MD, PhD, Hôpital de la Croix-Rousse
- Investigators
- jean-charles picaud, MD, PhD, Principal investigator, Hopital de la croix rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686801
- Sponsor's protocol ID
- OPTIPREMA
- Acronym
- OPTIPREMA
- Status last verified
- Aug 2018
- First submitted
- 2 Feb 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Larcade J, Pradat P, Buffin R, Leick-Courtois C, Jourdes E, Picaud JC. Estimation of Fat-free Mass at Discharge in Preterm Infants Fed With Optimized Feeding Regimen. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):115-118. doi: 10.1097/MPG.0000000000001261.
PubMed 27149252
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Body Composition at Discharge and Fat-Free Mass as an Indicator of Neurological Development at 2 Years in Very Preterm Infants : OPTIPREMA Study
- ClinicalTrials.gov ID
- NCT02686801
- Acronym / sponsor ID
- OPTIPREMA / OPTIPREMA
- Conditions
- Premature Birth of Newborn
- Keywords
- nutrition, prematurity, body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Feb 2016 (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.
This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development.
Detailed description
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Recent data from the literature show that it is possible - with appropriate nutritional care - to reduce the initial weight loss and to ensure that the growth deficit accumulated is then less important than was previously observed. The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (12-18 g/kg.day according to postconceptional age). Children often grow slowly during the first 10 days of life, so they accumulate a growth deficit that should be compensated secondarily. Therefore, optimum postnatal growth is 20 g/kg.day, rather than 15 g/kg.day. It is also important to assess the quality of growth, particularly fat free mass. The objective of nutritional care is dual: a sufficient weight gain (close to fetal growth rate) but also a relevant body composition. However, there is very little data on body composition of premature babies at discharge. It is now possible to measure quickly (one minute), simply and noninvasively using pediatric air-displacement plethysmography. Previous studies using more complex search techniques to implement (dual energy X-ray absorptiometry) showed excessive body fat at discharge in premature babies. Reference values collected using pediatric air-displacement plethysmography were published in 2011. Nutritional practices and strategies have significantly evolved in the past years to support such objectives: improvement of early parenteral nutrient intake, new fortifiers for human milk, new preterm formulas and early beginning of enteral nutrition. Individualized fortification of human milk helps to provide preterm infants with sufficient amount of nutrients. The modern nutritionnal care in preterm infants results in earlier and higher protein and energy intakes than previously performed. It improves some anthropometric parameters but little is know about body composition at discharge. Furthermore, exposition to high nutrients intake could lead to metabolic and hormonal imprinting with an increased risk of diabetes and cardio-vascular diseases in adulthood.
OPTIPREMA aim to focus the link between nutrient intakes during hospitalization, body composition at discharge and relationship between fat free mass variations at discharge and neurodevelopment at 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates
Key inclusion criteria (3 listed)
- Preterm newborns (less or equal to 32 weeks gestation and / or birthweight less or equal to1500g).
- Admitted in the Neonatal unit before day-of-life 7, staying at least 15 days in the unit, and discharged home at ≥ 35 weeks postconceptional age directly from the neonatal unit (no transfer)
- Oral Parental consent
Key exclusion criteria (4 listed)
- Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with pediatric air-displacement plethysmography
- Pathology inducing neurodevelopment troubles
- Transfer in an other hospital before discharge
- Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with pediatric air-displacement plethysmography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fat free mass at discharge
Time frame: pediatric air-displacement plethysmography measurement will be done at 36 to 40 weeks postconceptional age
Fat-fee mass percentage at discharge by pediatric air-displacement plethysmography After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, pediatric air-displacement plethysmography is performed in the last week of hospitalization. Body composition estimation is completed by clinical and demographic data collection and collection of information about neonatal nutrition.
6 secondary outcomes
Factors (clinical characteristics at birth and morbidity, feeding regimen) influencing body composition at discharge
Time frame: pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Prediction of fat free mass at discharge
Time frame: pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Anthropometric parameters at discharge and at 2 years
Time frame: measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age
Body mass index at discharge and at 2 years
Time frame: measurements will be done at 36 to 40 weeks postconceptional age and at 2 years of age
Fat free mass in preterm infants fed human milk fortified in an individualized way
Time frame: pediatric air-displacement plethysmography will be done at 36 to 40 weeks postconceptional age
Developmental score as measured by an appropriate neurodevelopmental test at 2 years
Time frame: Neurodevelopmental assessment at 2 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 27149252Larcade J, Pradat P, Buffin R, Leick-Courtois C, Jourdes E, Picaud JC. Estimation of Fat-free Mass at Discharge in Preterm Infants Fed With Optimized Feeding Regimen. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):115-118. doi: 10.1097/MPG.0000000000001261.
- Individual participant dataSharing planned: Undecided
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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.
jean-charles picaud, MD, PhD principal investigator
Hopital de la croix rousse
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 Premature Birth of Newborn, run by Hôpital de la Croix-Rousse 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 3 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: status not confirmed, as of the sponsor's last update on 15 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jean-charles picaud, MD, PhD (0033472001550, jean-charles.picaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat free mass at discharge (time frame: pediatric air-displacement plethysmography measurement will be done at 36 to 40 weeks postconceptional age). 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 NCT02686801, 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 15 Aug 2018.