Premature BirthNCT05071508
US and Neurodevelopmental Outcomes in the Neonatal Intensive Care Unit (NICU)
An observational study of Premature Birth, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a… Read more about this study
- Who is it for?
- Ages 25 to 34 weeks
- Conditions the study is for
- Premature Birth
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 31 Dec 2022
- 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 25 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants
Who may be able to join
- preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
- medically stable at time of air displacement measurements
Who cannot join
- infants that require medical support preventing ADP measurements from being taken
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit
The objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a population at risk for developmental delay, obesity, and metabolic disease. The investigators expect that a better understanding of these relationships will lead to the incorporation of ultrasound into routine nutritional management of preterm infants and allow for future optimization of their overall health and development.
Read the detailed description
The specific aims are as follows:
- To identify clinical factors that are associated with muscle and adipose tissue measurements. The investigators will examine the relationship between clinical factors such as calorie and protein intake during hospitalization, days on parenteral nutrition, C-Reactive Protein and other clinical surrogates for inflammation and both muscle and adipose tissue measured bi-weekly using bedside ultrasound. The investigators will collect anthropometric and ultrasound measurements bi-weekly and whole body composition (utilizing ADP) data at 35 weeks postmenstrual age (PMA)/discharge from the Neonatal Intensive Care Unit. All other clinical data will be collected throughout the hospital stay.
- To determine whether muscle thickness and cross-sectional area are predictive of improved neurodevelopmental outcomes. The investigators will assess the relationship between ultrasound measurements of muscle with neurodevelopmental outcomes at 35 weeks PMA/discharge and 4 months corrected age. The investigators will utilize Event Related Potentials (ERP) to measure speed of processing and recognition memory as early markers of brain development.
- To determine whether measurements of adipose tissue are predictive of later adverse metabolic outcomes. The investigators will assess the relationship between adipose tissue thickness and blood pressure and total body adiposity (using air-displacement plethysmography) at 35 weeks PMA/discharge and 4 months corrected age.
- Conditions
- 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 |
|---|---|---|
| Preterm Infants | Premature infants (born between 25 and 34 + 6 weeks gestational age) admitted to the University of Minnesota Masonic Children's Hospital NICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure at 35 weeks
blood pressure (systolic and diastolic)
Measured: 35 weeks corrected age
Blood pressure at 4 mo
blood pressure (systolic and diastolic)
Measured: 4 months corrected age
Weight data inpatient
weight in kg
Measured: 35 weeks corrected age
Length data inpatient
length in cm
Measured: 35 weeks corrected age
Weight data outpatient
weight in kg
Measured: 4 months corrected age
Length data outpatient
length in cm
Measured: 4 months corrected age
Fat mass inpatient
fat mass (kg)
Measured: 35 weeks corrected age
Fat-free mass inpatient
fat-free mass (kg)
Measured: 35 weeks corrected age
Percent body fat inpatient
percent body fat (kg/kg)
Measured: 4 months corrected age
Fat mass outpatient
fat mass (kg)
Measured: 4 months corrected age
Fat-free mass outpatient
fat-free mass (kg)
Measured: 4 months corrected age
Percent body fat outpatient
percent body fat (kg/kg)
Measured: 4 months corrected age
Ultrasound adipose measures inpatient
adipose tissue (cm)
Measured: 35 weeks corrected age
Ultrasound muscle measures inpatient
muscle thickness (cm)
Measured: 35 weeks corrected age
Ultrasound adipose measures outpatient
adipose tissue (cm)
Measured: 4 months corrected age
Ultrasound muscle measures outpatient
muscle measurements (cm)
Measured: 4 months corrected age
ERP data inpatient
ERP paradigm
Measured: 35 weeks corrected age
ERP data outpatient
ERP paradigms
Measured: 4 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start20 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 MinnesotaThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara E Ramel, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071508
- Sponsor's protocol ID
- PEDS-2020-28483
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2019
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Bedside Ultrasound to Predict and Optimize Metabolic and Neurodevelopmental Outcomes in Premature Infants in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05071508
- Acronym / sponsor ID
- PEDS-2020-28483
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- 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 objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a population at risk for developmental delay, obesity, and metabolic disease. The investigators expect that a better understanding of these relationships will lead to the incorporation of ultrasound into routine nutritional management of preterm infants and allow for future optimization of their overall health and development.
Detailed description
The specific aims are as follows:
- To identify clinical factors that are associated with muscle and adipose tissue measurements. The investigators will examine the relationship between clinical factors such as calorie and protein intake during hospitalization, days on parenteral nutrition, C-Reactive Protein and other clinical surrogates for inflammation and both muscle and adipose tissue measured bi-weekly using bedside ultrasound. The investigators will collect anthropometric and ultrasound measurements bi-weekly and whole body composition (utilizing ADP) data at 35 weeks postmenstrual age (PMA)/discharge from the Neonatal Intensive Care Unit. All other clinical data will be collected throughout the hospital stay.
- To determine whether muscle thickness and cross-sectional area are predictive of improved neurodevelopmental outcomes. The investigators will assess the relationship between ultrasound measurements of muscle with neurodevelopmental outcomes at 35 weeks PMA/discharge and 4 months corrected age. The investigators will utilize Event Related Potentials (ERP) to measure speed of processing and recognition memory as early markers of brain development.
- To determine whether measurements of adipose tissue are predictive of later adverse metabolic outcomes. The investigators will assess the relationship between adipose tissue thickness and blood pressure and total body adiposity (using air-displacement plethysmography) at 35 weeks PMA/discharge and 4 months corrected age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Infants | – | –Premature infants (born between 25 and 34 + 6 weeks gestational age) admitted to the University of Minnesota Masonic Children's Hospital NICU |
Who may qualify
- Ages
- 25 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants
Key inclusion criteria (2 listed)
- preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
- medically stable at time of air displacement measurements
Key exclusion criteria (1 listed)
- infants that require medical support preventing ADP measurements from being taken
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
Blood pressure at 35 weeks
Time frame: 35 weeks corrected age
blood pressure (systolic and diastolic)
Blood pressure at 4 mo
Time frame: 4 months corrected age
blood pressure (systolic and diastolic)
Weight data inpatient
Time frame: 35 weeks corrected age
weight in kg
Length data inpatient
Time frame: 35 weeks corrected age
length in cm
Weight data outpatient
Time frame: 4 months corrected age
weight in kg
Length data outpatient
Time frame: 4 months corrected age
length in cm
Fat mass inpatient
Time frame: 35 weeks corrected age
fat mass (kg)
Fat-free mass inpatient
Time frame: 35 weeks corrected age
fat-free mass (kg)
Percent body fat inpatient
Time frame: 4 months corrected age
percent body fat (kg/kg)
Fat mass outpatient
Time frame: 4 months corrected age
fat mass (kg)
Fat-free mass outpatient
Time frame: 4 months corrected age
fat-free mass (kg)
Percent body fat outpatient
Time frame: 4 months corrected age
percent body fat (kg/kg)
Ultrasound adipose measures inpatient
Time frame: 35 weeks corrected age
adipose tissue (cm)
Ultrasound muscle measures inpatient
Time frame: 35 weeks corrected age
muscle thickness (cm)
Ultrasound adipose measures outpatient
Time frame: 4 months corrected age
adipose tissue (cm)
Ultrasound muscle measures outpatient
Time frame: 4 months corrected age
muscle measurements (cm)
ERP data inpatient
Time frame: 35 weeks corrected age
ERP paradigm
ERP data outpatient
Time frame: 4 months corrected age
ERP paradigms
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 6 Feb 2025.
- 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.
Sara E Ramel, MD principal investigator
University of Minnesota
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 Minnesota 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 1 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 6 Feb 2025. 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?
Blood pressure at 35 weeks (time frame: 35 weeks corrected age). The study lists 18 primary outcomes in all. 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 6 Feb 2025.