- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325308
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ariel Salas, MD, MSPH
- Phone Number: 205-934-4680
- Email: asalas@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gestational age ≤ 28 weeks of gestation
- Postnatal age < 96 hours
Exclusion Criteria:
- Congenital malformations
- Chromosomal anomalies
- Terminal illness needing to limit or withhold support
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protein-enriched human milk diet
Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.
|
1.2 g of human-based protein will be added to each 100 ml of human milk administered
|
Active Comparator: Usual human milk diet
Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.
|
Human-based protein will not be added to the human milk administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat-free Mass(FFM)-For-age Z-score
Time Frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
|
Estimated by air displacement plethysmography.
FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019).
A Z-score of 0 represents the population mean.
Z-score values closer to 0 represent a better outcome.
No relevant thresholds have been defined.
|
36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat Mass(FM)-For-age Z-score
Time Frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
|
Estimated by air displacement plethysmography.
FM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019).
A Z-score of 0 represents the population mean.
Z-score values closer to 0 represent a better outcome.
No relevant thresholds have been defined.
|
36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
|
Body Fat(BF)-For-age Z-score
Time Frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
|
Body fat estimated by air displacement plethysmography.
BF measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019).
A Z-score of 0 represents the population mean.
Z-score values closer to 0 represent a better outcome.
No relevant thresholds have been defined.
|
36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
|
Anthropometric Measurements
Time Frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
|
Weight, length, and head circumference measurements. Measurements were converted into Z-scores based on Fenton growth curves (2013). They were calculated at birth and at 36 weeks. This outcome represents the change in weight, length, and head circumference Z-score during the course of the study (i.e., the Z-score at birth was subtracted from the Z-score at 36 weeks). A value of 0 represents that the infant's Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's Z-score during the study; negative values indicate the decrease in the infant's Z-score during the study. |
Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
|
Growth Rate
Time Frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
|
Weight gain in g/kg/day
|
Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
|
Number of Participants With Postnatal Growth Failure
Time Frame: 36 weeks or hospital discharge (whichever occurred first)
|
Diagnosis of growth failure (weight < 10th percentile using the 2013 Fenton growth curves)
|
36 weeks or hospital discharge (whichever occurred first)
|
Number of Participants With Diagnosis of Necrotizing Enterocolitis
Time Frame: From birth up to 120 days following birth
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Diagnosis of necrotizing enterocolitis stage 2 or 3
|
From birth up to 120 days following birth
|
Number of Participants With Diagnosis of Intestinal Perforation
Time Frame: From birth up to 120 days following birth
|
Diagnosis of intestinal perforation
|
From birth up to 120 days following birth
|
Death
Time Frame: Birth to 120 days
|
Death prior to 121 days of life
|
Birth to 120 days
|
Culture-proven Sepsis
Time Frame: Birth to 120 days
|
Diagnosis of sepsis with positive blood cultures
|
Birth to 120 days
|
Number of Days Alive and Receiving Full Enteral Feeding
Time Frame: Birth to 28 days
|
Time to full enteral feeding days
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Birth to 28 days
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Number of Episodes of Feeding Intolerance
Time Frame: Birth to 28 days
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Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
|
Birth to 28 days
|
Duration of Hospital Stay in Days
Time Frame: Birth to 120 days or discharge, whichever occurs first
|
From day of admission to day of hospital discharge to home
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Birth to 120 days or discharge, whichever occurs first
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Serum BUN
Time Frame: Birth to 28 days
|
Highest serum BUN value in the first 28 days after birth
|
Birth to 28 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Intestinal Microbiome
Time Frame: Birth to 36 weeks postmenstrual age
|
Determined by molecular analyses of fecal samples
|
Birth to 36 weeks postmenstrual age
|
Cognitive Outcomes
Time Frame: 2 years of corrected age
|
Determined by Bayley assessment
|
2 years of corrected age
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ariel Salas, MD, MSPH, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300005089
- K23HD102554 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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