Premature BirthNCT02622373
Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition
An observational study of Premature Birth and Preterm Birth, run by Vishal Pandey, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature. Read more about this study
- Who is it for?
- Ages 23 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Preterm Birth
- What is being tested?
- PEA POD Infant Body Composition System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2016
- 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 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study group involves premature infants born between 23 to 32 weeks gestation, while babies born at 34 weeks, 36 weeks and ≥37 and ≤ 42 weeks gestational age will serve as control groups.
Who may be able to join
- Newborns <32 weeks gestational age, singleton or multiple gestation
- 34-36 weeks gestational age newborns
- Term healthy infants from uncomplicated pregnancy
Who cannot join
- Babies with life threatening illness unlikely to survive
- Congenital and chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature.
Read the detailed description
Babies born premature weigh significantly less at the time of hospital discharge when compared to babies born at the corresponding age. The researchers in this study believe that the lower body weight at discharge may be due to lower muscle mass. However, there is no such information available for that at this time. It is important to have this information as babies who weigh less than normal at hospital discharge may develop higher blood pressure and higher sugar levels when they are 10-15 years old.
By doing this study, researchers will be able to have information about the baby's muscle mass, which will help the researchers to provide better nutrition to babies who are born premature. Researchers will also be able to determine if there are any differences in the muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a combination of breast milk and formula). This information may be beneficial in helping to promote the appropriate type of feeding for babies born premature.
- Conditions
- Premature Birth, Preterm Birth
- Being tested
- PEA POD Infant Body Composition System
- Keywords
- Pea Pod, 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.
PEA POD Infant Body Composition SystemDevice
The non-invasive device used in this study to measure a baby's body composition is a called a Pea Pod. The Pea Pod is a quick, safe, non-invasive and reliable bedside procedure used to measure changes in infant body composition.
| Study group | Role | What they receive |
|---|---|---|
| Birth Between 23-32 Weeks Gestation | Babies born between 23-32 weeks of gestational age will have their body composition determined using PEA POD Infant Body Composition System at 34 weeks, 36 weeks and 40 weeks of corrected age. Receives: Device: PEA POD Infant Body Composition System | |
| Birth Between 34-36 Weeks Gestation | Babies born at 34 weeks and 36 weeks of gestational age will have their body composition measured using PEA POD Infant Body Composition System as soon as they are off parenteral nutrition and receiving full enteral nutrition. Receives: Device: PEA POD Infant Body Composition System | |
| Birth at Term | Body composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge. Receives: Device: PEA POD Infant Body Composition System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fat mass percentage between 36 and 40 weeks in preterm infants
Body composition as determined by the PEA POD air displacement plathesmography would determine the fat mass percentage and the serial measure of this parameter would determine the changes in the fat mass percentage indicating the quality of growth between 36 and 40 weeks post conceptional age. At 40 weeks corrected age, the fat mass percentage of the premature infants would be compared with ten healthy term infants born to healthy mothers with uncomplicated pregnancies.
Measured: Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age
Secondary outcomes (1)
Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.
The Fat mass percentage in preterm infants at the 40 weeks corrected age would be compared with healthy full term infants born following an uncomplicated pregnancy.
Measured: 40 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionJan 2016
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 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vishal Pandey, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vishal Pandey, M.D., University of Kansas Medical Center
- Investigators
- Vishal Pandey, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622373
- Sponsor's protocol ID
- STUDY00002323
- Status last verified
- Jul 2016
- First submitted
- 16 Nov 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Roze JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.
PubMed 24808483
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition
- ClinicalTrials.gov ID
- NCT02622373
- Acronym / sponsor ID
- STUDY00002323
- Conditions
- Premature Birth, Preterm Birth
- Keywords
- Pea Pod, Body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vishal Pandey, M.D.University, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Dec 2015 (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 gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature.
Detailed description
Babies born premature weigh significantly less at the time of hospital discharge when compared to babies born at the corresponding age. The researchers in this study believe that the lower body weight at discharge may be due to lower muscle mass. However, there is no such information available for that at this time. It is important to have this information as babies who weigh less than normal at hospital discharge may develop higher blood pressure and higher sugar levels when they are 10-15 years old.
By doing this study, researchers will be able to have information about the baby's muscle mass, which will help the researchers to provide better nutrition to babies who are born premature. Researchers will also be able to determine if there are any differences in the muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a combination of breast milk and formula). This information may be beneficial in helping to promote the appropriate type of feeding for babies born premature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Birth Between 23-32 Weeks Gestation | – | Device: PEA POD Infant Body Composition SystemBabies born between 23-32 weeks of gestational age will have their body composition determined using PEA POD Infant Body Composition System at 34 weeks, 36 weeks and 40 weeks of corrected age. |
| Birth Between 34-36 Weeks Gestation | – | Device: PEA POD Infant Body Composition SystemBabies born at 34 weeks and 36 weeks of gestational age will have their body composition measured using PEA POD Infant Body Composition System as soon as they are off parenteral nutrition and receiving full enteral nutrition. |
| Birth at Term | – | Device: PEA POD Infant Body Composition SystemBody composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge. |
Who may qualify
- Ages
- 23 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study group involves premature infants born between 23 to 32 weeks gestation, while babies born at 34 weeks, 36 weeks and ≥37 and ≤ 42 weeks gestational age will serve as control groups.
Key inclusion criteria (3 listed)
- Newborns <32 weeks gestational age, singleton or multiple gestation
- 34-36 weeks gestational age newborns
- Term healthy infants from uncomplicated pregnancy
Key exclusion criteria (2 listed)
- Babies with life threatening illness unlikely to survive
- Congenital and chromosomal anomalies
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 |
|---|---|---|
| PEA POD Infant Body Composition SystemThe non-invasive device used in this study to measure a baby's body composition is a called a Pea Pod. The Pea Pod is a quick, safe, non-invasive and reliable bedside procedure used to measure changes in infant body composition. | Device | Birth Between 23-32 Weeks Gestation, Birth Between 34-36 Weeks Gestation, Birth at Term |
Primary outcome
Change in the Fat mass percentage between 36 and 40 weeks in preterm infants
Time frame: Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age
Body composition as determined by the PEA POD air displacement plathesmography would determine the fat mass percentage and the serial measure of this parameter would determine the changes in the fat mass percentage indicating the quality of growth between 36 and 40 weeks post conceptional age. At 40 weeks corrected age, the fat mass percentage of the premature infants would be compared with ten healthy term infants born to healthy mothers with uncomplicated pregnancies.
1 secondary outcome
Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.
Time frame: 40 weeks corrected 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 20 Jul 2016.
- Background: PubMed 24808483Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Roze JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.
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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.
Vishal Pandey, MD principal investigator
University of Kansas Medical Center
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 and Preterm Birth, run by Vishal Pandey, M.D. 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 3 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: finished, as of the sponsor's last update on 20 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 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?
Change in the Fat mass percentage between 36 and 40 weeks in preterm infants (time frame: Change in the Fat mass percentage between 36 weeks and 40 weeks corrected 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 NCT02622373, 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 20 Jul 2016.