Preterm BirthNCT02855814
Body Composition Reference Data for Preterm Infants
An observational study of Preterm Birth, run by University of Minnesota.
Trial summary
The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Body Composition
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to 1 Jun 2020
- 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 24 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: AGA, singleton, healthy infants born between 30+0 and 36+6 weeks gestation were eligible. The study was conducted between 2010 and 2015 at three tertiary NICU's in the United States: the University of Minnesota Masonic Children's Hospital in Minneapolis, MN (referred to hereafter as the MN site), Santa Clara Valley Medical Center in San Jose, CA (referred to as the SC site), and Baystate Medical Center in Springfield, MA (referred to as BS).
Who may be able to join
- Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age
Who cannot join
- Congenital defects that affect growth
- Inability to tolerate room air for 5 minutes without desaturation or bradycardia
- <1 kg birth weight
- Parents did not provide consent
About this study
The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.
- Conditions
- Preterm Birth
- Being tested
- 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.
Body CompositionOther
No intervention. This is an observational, normative study of body composition variation in preterm infants
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Total body fat mass measured by air displacement plethysmography, in kg
Measured: Within 72 hours of birth
Fat-free mass
Total body fat-free mass measured by air displacement plethysmography, in kg
Measured: Within 72 hours of birth
Percent body fat
Percent body fat measured by air displacement plethysmography, in %
Measured: Within 72 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJun 2010
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
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
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Medical Center, Baystate Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855814
- Sponsor's protocol ID
- 1001M76732
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Demerath EW, Johnson W, Davern BA, Anderson CG, Shenberger JS, Misra S, Ramel SE. New body composition reference charts for preterm infants. Am J Clin Nutr. 2017 Jan;105(1):70-77. doi: 10.3945/ajcn.116.138248. Epub 2016 Nov 2.
PubMed 27806978
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Reference Data for Preterm Infants
- ClinicalTrials.gov ID
- NCT02855814
- Acronym / sponsor ID
- 1001M76732
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Santa Clara Valley Medical Center, Baystate Medical Center
- Study start
- Jun 2010 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 4 Aug 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.
The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- AGA, singleton, healthy infants born between 30+0 and 36+6 weeks gestation were eligible. The study was conducted between 2010 and 2015 at three tertiary NICU's in the United States: the University of Minnesota Masonic Children's Hospital in Minneapolis, MN (referred to hereafter as the MN site), Santa Clara Valley Medical Center in San Jose, CA (referred to as the SC site), and Baystate Medical Center in Springfield, MA (referred to as BS).
Key inclusion criteria (1 listed)
- Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age
Key exclusion criteria (4 listed)
- Congenital defects that affect growth
- Inability to tolerate room air for 5 minutes without desaturation or bradycardia
- <1 kg birth weight
- Parents did not provide consent
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 |
|---|---|---|
| Body CompositionNo intervention. This is an observational, normative study of body composition variation in preterm infants | Other | – |
Primary outcome
Fat mass
Time frame: Within 72 hours of birth
Total body fat mass measured by air displacement plethysmography, in kg
Fat-free mass
Time frame: Within 72 hours of birth
Total body fat-free mass measured by air displacement plethysmography, in kg
Percent body fat
Time frame: Within 72 hours of birth
Percent body fat measured by air displacement plethysmography, in %
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 2 Mar 2022.
- Derived from this study: PubMed 27806978Demerath EW, Johnson W, Davern BA, Anderson CG, Shenberger JS, Misra S, Ramel SE. New body composition reference charts for preterm infants. Am J Clin Nutr. 2017 Jan;105(1):70-77. doi: 10.3945/ajcn.116.138248. Epub 2016 Nov 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University of Minnesota.
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 1 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Fat mass (time frame: Within 72 hours of birth). The study lists 3 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 NCT02855814, 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 2 Mar 2022.