Microbial Colonization Clinical Trial
Official title:
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
Verified date | March 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | September 30, 2025 |
Est. primary completion date | January 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 4 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Salas AA, Gunawan E, Nguyen K, Reeves A, Argent V, Finck A, Carlo WA. Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial. Pediatrics. 2023 Sep 1;152(3):e2023061603. doi: 10.1542/peds.2023-061603. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in Intestinal Microbiome | Determined by molecular analyses of fecal samples | Birth to 36 weeks postmenstrual age | |
Other | Cognitive Outcomes | Determined by Bayley assessment | 2 years of corrected age | |
Primary | Fat-free Mass(FFM)-For-age Z-score | 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 | Fat Mass(FM)-For-age Z-score | 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 | |
Secondary | Body Fat(BF)-For-age Z-score | 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 | |
Secondary | Anthropometric Measurements | 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) | |
Secondary | Growth Rate | Weight gain in g/kg/day | Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first) | |
Secondary | Number of Participants With Postnatal Growth Failure | Diagnosis of growth failure (weight < 10th percentile using the 2013 Fenton growth curves) | 36 weeks or hospital discharge (whichever occurred first) | |
Secondary | Number of Participants With Diagnosis of Necrotizing Enterocolitis | Diagnosis of necrotizing enterocolitis stage 2 or 3 | From birth up to 120 days following birth | |
Secondary | Number of Participants With Diagnosis of Intestinal Perforation | Diagnosis of intestinal perforation | From birth up to 120 days following birth | |
Secondary | Death | Death prior to 121 days of life | Birth to 120 days | |
Secondary | Culture-proven Sepsis | Diagnosis of sepsis with positive blood cultures | Birth to 120 days | |
Secondary | Number of Days Alive and Receiving Full Enteral Feeding | Time to full enteral feeding days | Birth to 28 days | |
Secondary | Number of Episodes of Feeding Intolerance | Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination | Birth to 28 days | |
Secondary | Duration of Hospital Stay in Days | From day of admission to day of hospital discharge to home | Birth to 120 days or discharge, whichever occurs first | |
Secondary | Serum BUN | Highest serum BUN value in the first 28 days after birth | Birth to 28 days |
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