Preterm Infants Fed a Human Milk Fortifier
ConditionGrowth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAbbott Nutrition
About this trial
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Birth weight between 700 g-1500 g.
≤ 32 weeks and 0 days GA at birth.
Participant has been classified as appropriate for GA (AGA).
Enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0)
Disqualifiers
Enteral feeding of preterm infant formula or HMF for > 7 days.
Expected to be transferred to another facility within 30 days of randomization.
Serious congenital abnormalities or underlying disease that may affect growth and development.
5-minute APGAR ≤ 4.
Trial design
Design model
Parallel
Treatments tested in this trial
Control Product
Other interventionFed from Study Day 1
Experimental Product 1
Other interventionFed from Study Day 1
Experimental Product 2
Other interventionFed from Study Day 1
Treatment groups
321 Participants
are divided into 3 treatment groupsGroup A: Control ProductActive comparator 1 intervention
Group B: Product 1Experimental treatment 1 intervention
Group C: Product 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Weight
Weight gain per day
Time frame
Study Day 1 to Study Day 29 or Hospital Discharge if firstSecondary outcomes
1
Length
Length gains per week
Time frame
Study Day 1 to Study Day 15 and Study Day 292
Length
Attained length in cm
Time frame
Study Day 1, 8, 15, 22, 29 and Hospital Discharge3
Head Circumference
Head circumference gains per week
Time frame
Study Day 1 to Study Day 15 and Study Day 294
Head Circumference (HC)
Attained HC in cm
Time frame
Study Day 1, 8, 15, 22, 29 and Hospital DischargeOther outcomes
1
Blood Chemistries
Electrolytes, minerals, BUN, alkaline phosphatase
Time frame
Study Day 1 to Study Day 292
Medications
Medication usage including frequency and reason for use
Time frame
Study Day 1 to Study Day 293
Length of Stay
Number of days in hospital
Time frame
From birth until Discharge, typically 60 days4
Stool Sample
Characterization of microbiota, immunity
Time frame
Study Day 1 to Study Day 29Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: