Nutrition of Premature Infants With Human Breastmilk Fortifier (NCT03191617) | Clinical Trial Compass
UnknownNot Applicable
Nutrition of Premature Infants With Human Breastmilk Fortifier
Chile160 participantsStarted 2015-09
Plain-language summary
The objective of the study is to compare two human milk fortifiers with different protein content and LCPUFA in a group of very low birth weight infants.
Who can participate
Age range3 Days – 40 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:
* Premature infant equal or under 31 weeks gestational age at birth
* Birth weight equal or under 1,250 g
* Predominantly fed breast milk (mother's milk or donor milk) on study day 0
* Appropriate birth weight for gestational age (AGA) - defined as birth weight between and inclusive of the 10th and 90th percentiles on the Fenton growth chart
* Singleton or twin birth (both twins do not need to qualify and be randomized into study)
* Birth weight is ≤1,000 g and participant is ≤ 40 days of age on study day 0
* Birth weight is above 1,000 g and participant is ≤ 30 days of age on study day 0
* Enteral intake of 80 mL/kg/d of unfortified breast milk on study day 0
* Anticipate mother's willingness to breast milk for at least 28 days from study day 0
* Signed informed consent obtained
Exclusion Criteria:
* History of underlying metabolic or chronic disease, congenital malformation, or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the participant to ingest food, normal growth and development of the participant, or the evaluation of the participant
* 5 minute APGAR score ≤ 4
* Major surgery that required general anesthesia prior to first day study (note: persistent ductus arterious ligation is allowed)
* Received pharmacologic doses of glucocorticoids during 3 consecutive days (72 hours) prior to or on day one of study (physiologic hydrocortisone administration up to 1.5 mg/kg/d is permitted)
* Venti…
What they're measuring
1
Weight and linear growth
Timeframe: between entering study and 45 days in study or discharge, whatever first