Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants (NCT03214822) | Clinical Trial Compass
CompletedNot Applicable
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
Canada30 participantsStarted 2017-08-01
Plain-language summary
This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in premature infants.
Who can participate
Age range7 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:
* Male or female infant with birth weight \<1250 grams
* Gestational age between 26+0 to 30+0 weeks at birth
* Able to adhere to feeding protocol
* Parenteral nutrition must be started by day of life 2
* Enteral feeding \>80 ml/kg/d should be reached by day of life 14
* Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
* In the investigator's opinion, the subject's parent(s)/legal guardian(s) understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
Exclusion Criteria:
* Gestational age \> 30+0 weeks at birth (to guarantee a minimum of 3 weeks H2MF treatment, since fortification ends at 33+0 AGA)
* Gestational age \< 26+0 weeks at birth (to minimize baseline heterogeneity, since gestational age influences gut microbiota)
* Received antibiotics on the first day of specimen collection (to minimize baseline heterogeneity, since antibiotics influence gut microbiota) Note: all infants are expected to receive up to 48 hr antibiotic prophylaxis at birth according to standard NICU protocol; this criterion will exclude infants receiving extended courses of antibiotics.
* Received probiotics at any time (to minimize baseline heterogeneity, since probiotics influence gut microbiota)
* Unlikely to survive the study period
* Presence…
What they're measuring
1
Fecal microbiome composition at end of intervention
Timeframe: 33+0 weeks adjusted gestational age (end of intervention)
2
Fecal microbiome diversity at end of intervention
Timeframe: 33+0 weeks adjusted gestational age (end of intervention)
3
Fecal microbiome community structure at end of intervention
Timeframe: 33+0 weeks adjusted gestational age (end of intervention)