Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04325308
Other study ID # 300005089
Secondary ID K23HD102554
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 13, 2020
Est. completion date September 30, 2025

Study information

Verified date March 2024
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Protein-enriched human milk diet
1.2 g of human-based protein will be added to each 100 ml of human milk administered
Usual human milk diet
Human-based protein will not be added to the human milk administered.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT04122612 - Shaping Microbiome in the First 1,000 Days of Life
Not yet recruiting NCT05405634 - Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Not yet recruiting NCT04895774 - Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Completed NCT05175833 - Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19 Phase 2
Recruiting NCT04836910 - Microbiome and Polycystic Ovaries
Recruiting NCT05603650 - Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract N/A
Completed NCT04991818 - MSC - OneBiome UX Pilot Study N/A
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Recruiting NCT04140747 - Transfer of Strictly Anaerobe Microbes From Mother to Child
Recruiting NCT04111471 - The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Completed NCT03422562 - Probiotics and Intestinal Microbiome in Preterm Infants Phase 3
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1