Metabolic SyndromeNCT01947972
Individualized Maternal Milk Fortification for Feeding the Preterm Infants
A study testing Tailored protein fortification in people with Metabolic Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in… Read more about this study
- Who is it for?
- Ages 24 hours to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Tailored protein fortification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2013to Jul 2016
- 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 24 hours to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with gestational age ≤ 34weeks
- very low birth weight (≤ 1500g)
Who cannot join
- maternal health problems contradicting breastfeeding
- genetic or chromosomal abnormalities
- metabolic contraindications for increased amount of protein
Trial locations and contacts
1 site in 1 country.
About this study
Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in conjunction with complexity of prematurity, is likely to cause. Current study aims to investigate is whether individualized fortification of breast milk protein, based on the mother's milk protein content and targeting the recommended daily protein requirements, is associated with better nutrition, growth, biochemical and endocrine markers associated with the nutrition of preterm low birth weight neonates, compared to the standard fortification of human milk.
Read the detailed description
Proteins are of the most important macromolecules in living organisms participating in almost all biological processes. Premature infants are forced to adapt to a new (extrauterine) environment where supply of nutrients, including amino acids, from mother ceases abruptly. Consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively nutritional support, to promote brain development, achieve normal endocrine and metabolic function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth restriction during postnatal period and at the same time encouraging the analogue modulation of body composition (increased muscle mass, decrease body fat, hydration).
Malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without proper treatment could have serious consequences on psychomotor development and metabolic activity. Indeed, 75% of low birth weight premature infants exhibit extrauterine growth restriction at discharge, even when they have achieved growth equal to the considered satisfactory, ie 15g/kg/day.
Beyond anthropometrics differences between preterm and full-term newborns, body composition varies as well. Preterms have higher percentage of body fat and decreased muscle mass at term time compared with full term neonates. However, it has not been clarified whether this differentiation is harmful predisposing to chronic diseases later in childhood or adult life (eg. obesity, metabolic syndrome).
- Conditions
- Metabolic Syndrome
- Being tested
- Tailored protein fortification
- Keywords
- preterm neonate, tailored fortification, nutrition, maternal breast milk composition
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored protein fortificationDietary supplement
4-4.5g of protein/kg/d
| Study group | Role | What they receive |
|---|---|---|
| protein intake of 4g/kg/d | Other | Tailored protein fortification and nutritional status of preterm neonate. 4.5g protein per kg for preterms with body weight less than 1000g and 4g protein per kg for preterms with body weight more than 1000g, after human milk analysis. Intervention regards protein supplementation to fulfil the exact protein needs of preterms Receives: Dietary Supplement: Tailored protein fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean protein intake per kg of body weight between the groups
Measured: participants will be followed until discharge and at 40 weeks post gestational age
Secondary outcomes (4)
growth assessment differences between groups
Anthropometric differences in body length, head circumference, body weight gain/kg, mid arm circumference
Measured: participants will be followed until discharge and at 40 weeks post gestational age
Differences in bioelectrical impedance between groups
Measured: participants will be followed until discharge and at 40 weeks post gestational age
Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk
Measured: from the moment of intervention, at least once in 10days, and until the end of intervention
Biochemical (lipidemic profile differences) between groups
Measured: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisavet Parlapani, Aristotle University Of Thessaloniki
- Investigators
- Elisavet Diamanti, Dr, Principal investigator, AUTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947972
- Sponsor's protocol ID
- IKY5721
- Status last verified
- Jul 2016
- First submitted
- 10 Sep 2013
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Maternal Milk Fortification for Feeding the Preterm Infants
- ClinicalTrials.gov ID
- NCT01947972
- Acronym / sponsor ID
- IKY5721
- Conditions
- Metabolic Syndrome
- Keywords
- preterm neonate, tailored fortification, nutrition, maternal breast milk composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Sep 2013 (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 nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in conjunction with complexity of prematurity, is likely to cause. Current study aims to investigate is whether individualized fortification of breast milk protein, based on the mother's milk protein content and targeting the recommended daily protein requirements, is associated with better nutrition, growth, biochemical and endocrine markers associated with the nutrition of preterm low birth weight neonates, compared to the standard fortification of human milk.
Detailed description
Proteins are of the most important macromolecules in living organisms participating in almost all biological processes. Premature infants are forced to adapt to a new (extrauterine) environment where supply of nutrients, including amino acids, from mother ceases abruptly. Consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively nutritional support, to promote brain development, achieve normal endocrine and metabolic function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth restriction during postnatal period and at the same time encouraging the analogue modulation of body composition (increased muscle mass, decrease body fat, hydration).
Malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without proper treatment could have serious consequences on psychomotor development and metabolic activity. Indeed, 75% of low birth weight premature infants exhibit extrauterine growth restriction at discharge, even when they have achieved growth equal to the considered satisfactory, ie 15g/kg/day.
Beyond anthropometrics differences between preterm and full-term newborns, body composition varies as well. Preterms have higher percentage of body fat and decreased muscle mass at term time compared with full term neonates. However, it has not been clarified whether this differentiation is harmful predisposing to chronic diseases later in childhood or adult life (eg. obesity, metabolic syndrome).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| protein intake of 4g/kg/d | Other | Dietary Supplement: Tailored protein fortificationTailored protein fortification and nutritional status of preterm neonate. 4.5g protein per kg for preterms with body weight less than 1000g and 4g protein per kg for preterms with body weight more than 1000g, after human milk analysis. Intervention regards protein supplementation to fulfil the exact protein needs of preterms |
Who may qualify
- Ages
- 24 hours to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants with gestational age ≤ 34weeks
- very low birth weight (≤ 1500g)
Key exclusion criteria (3 listed)
- maternal health problems contradicting breastfeeding
- genetic or chromosomal abnormalities
- metabolic contraindications for increased amount of protein
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 |
|---|---|---|
| Tailored protein fortification4-4.5g of protein/kg/d | Dietary supplement | protein intake of 4g/kg/d |
Primary outcome
Mean protein intake per kg of body weight between the groups
Time frame: participants will be followed until discharge and at 40 weeks post gestational age
4 secondary outcomes
growth assessment differences between groups
Time frame: participants will be followed until discharge and at 40 weeks post gestational age
Differences in bioelectrical impedance between groups
Time frame: participants will be followed until discharge and at 40 weeks post gestational age
Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk
Time frame: from the moment of intervention, at least once in 10days, and until the end of intervention
Biochemical (lipidemic profile differences) between groups
Time frame: at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age
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 13 Jul 2016.
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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.
Elisavet Diamanti, Dr principal investigator
AUTH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored protein fortification in people with Metabolic Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 inclusion and 3 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 13 Jul 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 Greece. 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?
Mean protein intake per kg of body weight between the groups (time frame: participants will be followed until discharge and at 40 weeks post gestational age). 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 13 Jul 2016.