Prematurity Clinical Trial
— ENACT+Official title:
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial
Verified date | June 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Mead Johnson Nutrition |
United States,
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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