Active — Not RecruitingNot Applicable

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

United States80 participantsStarted 2022-11-17

Plain-language 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.

Who can participate

Age range1 Day – 4 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fat-free mass(FFM)-for-age Z-score

Timeframe: Postnatal day 14 to 21

Trial details

NCT IDNCT05525585

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

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