Premature BirthPREMANCT00833222
Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants
An observational study of Premature Birth, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35 weeks post-menstrual age (PMA)] premature infants. Read more about this study
- Who is it for?
- Ages 31 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2012
- 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 31 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature and full term infants admitted to the University of Utah Newborn Intensive Care Unit, Intermediate Nursery or Well Baby Nursery
Who may be able to join
- Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth
- Birth weight between the 5th and 95th percentile corrected for gestational age
Who cannot join
- Chromosomal abnormalities
- Major congenital anomalies
- Major surgery
- Severe CNS injury
- Inborn errors of metabolism
- Assisted ventilation
- Inability to start enteral feeds by 96 hours of age
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35 weeks post-menstrual age (PMA)] premature infants.
Read the detailed description
- To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
- To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
- To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
- Compare growth, body composition and bone strength between infants born preterm to infants born full term.
- Conditions
- Premature Birth
- Keywords
- premature birth
- 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 |
|---|---|---|
| Full Term Infants | Infants born between 37 4/7 weeks and 42 3/7 weeks gestation. | |
| Preterm Infants | Infants born between 32 4/7 weeks and 35 3/7 weeks gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth trajectory
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Moyer-Mileur, PhD, Principal investigator, University of UtahKristine Jordan, MPH, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833222
- Sponsor's protocol ID
- 24087
- Acronym
- PREMA
- Status last verified
- Dec 2017
- First submitted
- 29 Jan 2009
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT00833222
- Acronym / sponsor ID
- PREMA / 24087
- Conditions
- Premature Birth
- Keywords
- premature birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Feb 2009 (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 purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35 weeks post-menstrual age (PMA)] premature infants.
Detailed description
- To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
- To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
- To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
- Compare growth, body composition and bone strength between infants born preterm to infants born full term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Term Infants | – | –Infants born between 37 4/7 weeks and 42 3/7 weeks gestation. |
| Preterm Infants | – | –Infants born between 32 4/7 weeks and 35 3/7 weeks gestation. |
Who may qualify
- Ages
- 31 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature and full term infants admitted to the University of Utah Newborn Intensive Care Unit, Intermediate Nursery or Well Baby Nursery
Key inclusion criteria (2 listed)
- Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth
- Birth weight between the 5th and 95th percentile corrected for gestational age
Key exclusion criteria (7 listed)
- Chromosomal abnormalities
- Major congenital anomalies
- Major surgery
- Severe CNS injury
- Inborn errors of metabolism
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
Growth trajectory
Time frame: Weekly
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 26 Dec 2017.
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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.
Laurie Moyer-Mileur, PhD principal investigator
University of Utah
Kristine Jordan, MPH, PhD principal investigator
University of Utah
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, run by University of Utah at 1 site in United States.
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 7 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 26 Dec 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 United States. 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?
Growth trajectory (time frame: Weekly). 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 26 Dec 2017.