PreTerm BirthNCT03013374
Protein Balance and Body Composition in Preterm Infants
An observational study of PreTerm Birth and Human Milk, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants. Aim of the study is to investigate protein balance according to feeding regimen and the association between human milk feeding and fat free mass content at term… Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- PreTerm Birth, Human Milk
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Jun 2017
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants are enrolled at time of hospital discharge. Infants with gestational age ≤32 weeks, birth weight < 1500 grams and ≥10th percentile according to Fenton's growth chart, having stable clinical conditions and feeding by mouth with either exclusively human milk or formula at discharge were included. Exclusion criteria were the following: infants affected by either congenital or chromosomal abnormalities or conditions that could interfere with growth, such as chronic lung disease (as defined based on the classification of Jobe and Bancalari), neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).
Who may be able to join
- gestational age ≤32 weeks
- birth weight < 1500 grams
- birth weight ≥10th percentile according to Fenton's growth chart
- stable clinical conditions at discharge
- feeding by mouth with either exclusively human milk or formula at discharge
Who cannot join
- congenital or chromosomal abnormalities
- conditions that could interfere with growth such as chronic lung disease, neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Milan, 20122
Laura Morlacchi, MD, +39 0255032483, laura.morlacchi@mangiagalli.it
Laura Morlacchi, MD
About this study
Official title: Protein Balance and Body Composition in Preterm Infants According to Feeding Regimen
The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants.
Aim of the study is to investigate protein balance according to feeding regimen and the association between human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.
Read the detailed description
Nutritional management of preterm infants aims to approximate tissue growth and body composition of a foetus of same postconceptional age. The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain.
Aim of the study is to investigate protein balance according to feeding regimen and the association between exclusive human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.
A prospective observational study. Infants are included according to inclusion criteria. Enrollment is performed at hospital discharge. Infants are divided into two groups (exclusively human milk or exclusively formula) according to own mother's milk availability. At enrollment macronutrients' intakes and protein balance are determined. Anthropometric measurements and body composition are also assessed. Nutritional composition of human milk is calculated by infrared spectroscopy (MIRIS® AB, Uppsala, Sweden). Protein balance is determined according to nitrogen balance standard method. Body composition is assessed by an air-displacement plethysmography system system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). At term corrected age anthropometry and body composition assessments are repeated.
- Conditions
- PreTerm Birth, Human Milk
- Keywords
- protein accretion, body composition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Human milk fed infants | Infants fed fortified human milk at enrollment Any intervention is performed. Groups distinction is made according to own mother's milk availability. | |
| Preterm formula | Infants fed preterm formula milk at enrollment. Any intervention is performed. Groups distinction is made according to own mother's milk availability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein balance
Protein balance will be determined according to nitrogen balance standard method and defined as the difference between daily nitrogen intake and daily urinary nitrogen excretion. Nitrogen intake will be measured from the amount of total protein intake (i.e. grams of nitrogen intake=grams of protein intake/6.25).
Urinary urea nitrogen excretion will be considered representative of total nitrogen loss. Urinary urea will be calculated from urine specimens collected by cotton balls.
Measured: at hospital discharge (that is 35-36 post conceptional weeks)
Secondary outcomes (1)
Fat free mass content
Body composition will be assessed by an air-displacement plethysmography system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). The PEA POD assesses fat mass and fat-free mass by direct measurements of body mass and volume and the application of a classic densitometric model.
Measured: Term corrected age (that is 40 post conceptional weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (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 PreTerm BirthStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Morlacchi, MD, Principal investigator, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013374
- Sponsor's protocol ID
- Protein balance and FFM
- Status last verified
- Jan 2017
- First submitted
- 30 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Morlacchi L, Roggero P, Gianni ML, Bracco B, Porri D, Battiato E, Menis C, Liotto N, Mallardi D, Mosca F. Protein use and weight-gain quality in very-low-birth-weight preterm infants fed human milk or formula. Am J Clin Nutr. 2018 Feb 1;107(2):195-200. doi: 10.1093/ajcn/nqx001.
PubMed 29529139
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Balance and Body Composition in Preterm Infants According to Feeding Regimen
- ClinicalTrials.gov ID
- NCT03013374
- Acronym / sponsor ID
- Protein balance and FFM
- Conditions
- PreTerm Birth, Human Milk
- Keywords
- protein accretion, body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 6 Jan 2017 (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.
The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants.
Aim of the study is to investigate protein balance according to feeding regimen and the association between human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.
Detailed description
Nutritional management of preterm infants aims to approximate tissue growth and body composition of a foetus of same postconceptional age. The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain.
Aim of the study is to investigate protein balance according to feeding regimen and the association between exclusive human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.
A prospective observational study. Infants are included according to inclusion criteria. Enrollment is performed at hospital discharge. Infants are divided into two groups (exclusively human milk or exclusively formula) according to own mother's milk availability. At enrollment macronutrients' intakes and protein balance are determined. Anthropometric measurements and body composition are also assessed. Nutritional composition of human milk is calculated by infrared spectroscopy (MIRIS® AB, Uppsala, Sweden). Protein balance is determined according to nitrogen balance standard method. Body composition is assessed by an air-displacement plethysmography system system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). At term corrected age anthropometry and body composition assessments are repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human milk fed infants | – | –Infants fed fortified human milk at enrollment Any intervention is performed. Groups distinction is made according to own mother's milk availability. |
| Preterm formula | – | –Infants fed preterm formula milk at enrollment. Any intervention is performed. Groups distinction is made according to own mother's milk availability. |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants are enrolled at time of hospital discharge. Infants with gestational age ≤32 weeks, birth weight < 1500 grams and ≥10th percentile according to Fenton's growth chart, having stable clinical conditions and feeding by mouth with either exclusively human milk or formula at discharge were included. Exclusion criteria were the following: infants affected by either congenital or chromosomal abnormalities or conditions that could interfere with growth, such as chronic lung disease (as defined based on the classification of Jobe and Bancalari), neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).
Key inclusion criteria (5 listed)
- gestational age ≤32 weeks
- birth weight < 1500 grams
- birth weight ≥10th percentile according to Fenton's growth chart
- stable clinical conditions at discharge
- feeding by mouth with either exclusively human milk or formula at discharge
Key exclusion criteria (2 listed)
- congenital or chromosomal abnormalities
- conditions that could interfere with growth such as chronic lung disease, neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).
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
Protein balance
Time frame: at hospital discharge (that is 35-36 post conceptional weeks)
Protein balance will be determined according to nitrogen balance standard method and defined as the difference between daily nitrogen intake and daily urinary nitrogen excretion. Nitrogen intake will be measured from the amount of total protein intake (i.e. grams of nitrogen intake=grams of protein intake/6.25). Urinary urea nitrogen excretion will be considered representative of total nitrogen loss. Urinary urea will be calculated from urine specimens collected by cotton balls.
1 secondary outcome
Fat free mass content
Time frame: Term corrected age (that is 40 post conceptional weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 29529139Morlacchi L, Roggero P, Gianni ML, Bracco B, Porri D, Battiato E, Menis C, Liotto N, Mallardi D, Mosca F. Protein use and weight-gain quality in very-low-birth-weight preterm infants fed human milk or formula. Am J Clin Nutr. 2018 Feb 1;107(2):195-200. doi: 10.1093/ajcn/nqx001.
- 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.
Laura Morlacchi, MD principal investigator
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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 PreTerm Birth and Human Milk, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. 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 Italy. 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 Laura Morlacchi, MD (+39 0255032483, laura.morlacchi@mangiagalli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein balance (time frame: at hospital discharge (that is 35-36 post conceptional weeks)). 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 NCT03013374, 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 10 Jan 2017.