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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05525585
Other study ID # 300009921
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 17, 2022
Est. completion date October 2024

Study information

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

Clinical Trial Summary

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date October 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 4 Days
Eligibility Inclusion Criteria: - Gestational age 29 to 33 weeks of gestation - Birth weight < 1800 g - Postnatal age < 96 hours Exclusion Criteria: - Small for gestational age (<5th percentile) - Major congenital/chromosomal anomalies - Terminal illness needing withhold or limit support

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Early HMF
Mom's milk or donor milk will be fortified between postnatal day 4 and 7
Delayed HMF
Mom's milk or donor milk will be fortified between postnatal day 10 and 14

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat-free mass(FFM)-for-age Z-score Estimated by air displacement plethysmography Postnatal day 14 to 21
Secondary Fecal microbiome composition Determined by 16S RNA sequencing of bacteria in stool samples Birth to 36 weeks postmenstrual age
Secondary Growth - Weight Measured weekly in grams and z scores as part of routine care Birth to 36 weeks postmenstrual age or hospital discharge
Secondary Growth - Length Measured weekly in cm and z scores as part of routine care Birth to 36 weeks postmenstrual age or hospital discharge
Secondary Growth - Head circumference Measured weekly in cm and z scores as part of routine care Birth to 36 weeks postmenstrual age or hospital discharge
Secondary Growth rate Weight gain in g/kg/day Birth to 36 weeks postmenstrual age or hospital discharge
Secondary Number of participants with postnatal growth faltering Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2 Birth to 36 weeks postmenstrual age or hospital discharge
Secondary Number of participants with diagnosis of necrotizing enterocolitis Diagnosis of necrotizing enterocolitis stage 2 or 3 Birth to 60 days or discharge
Secondary Number of participants with diagnosis of intestinal perforation Diagnosis of intestinal perforation Birth to 10 days
Secondary Death Death prior to postnatal day 60 Birth to 60 days
Secondary Duration of hospital stay in days From day of admission to day of hospital discharge to home Birth to 60 days or discharge, whichever occurs first
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