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Infant Body Composition Assessment for Premature Infants
N/A
Waitlist Available
Led By Ariel A. Salas, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months of corrected age
Awards & highlights
Study Summary
This trial looks at whether measuring an infant's body composition could help reduce obesity later on.
Who is the study for?
This trial is for very preterm infants born between 28 and 32 weeks of gestation. It's not suitable for those with terminal illnesses where support is limited or withheld, or babies with gastrointestinal or neurologic malformations.Check my eligibility
What is being tested?
The study focuses on assessing body composition in these infants to see if early identification of changes in fat mass can reduce the percentage of body fat at the age of 3 months.See study design
What are the potential side effects?
Since this trial involves assessment rather than medication, there are no direct side effects related to drugs. However, handling and measuring procedures may cause discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months of corrected age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months of corrected age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Body Mass Index
Growth
Head Circumference
+2 moreOther outcome measures
Changes in Intestinal Microbiome
Changes in Metabolic Pathways
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).
Group II: Control GroupActive Control1 Intervention
Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,979 Total Patients Enrolled
73 Trials studying Obesity
474,130 Patients Enrolled for Obesity
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,604 Total Patients Enrolled
40 Trials studying Obesity
254,230 Patients Enrolled for Obesity
Ariel A. Salas, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
196 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have issues with my digestive system or nervous system.You have a serious, life-threatening illness and need special care or may not receive certain treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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