Transition From Donor Milk: a Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28+
SponsorAugusta University
About this trial
Preterm and very low birth weight (VLBW, \< 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. The investigators hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Greater than 1,250 grams
At least 28 days of life
Diet consisting of donor human milk with/without mother's own milk
Disqualifiers
Birth weight below the 5th percentile
History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
Congenital anomalies
Care team discretion
Trial design
Design model
Single group
Treatments tested in this trial
Preterm Infant Formula
Dietary supplementTransition from donor human milk to preterm infant formula
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Donor MilkNo intervention 0 interventions
Group B: Preterm Infant FormulaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight Velocity
Weight velocity between birth and 36 weeks post menstrual age
Time frame
36 weeks post menstrual age2
Fat free mass
Fat free mass at 36 weeks post menstrual age
Time frame
36 weeks post menstrual ageSecondary outcomes
1
Number of Patients with Bronchopulmonary dysplasia
Time frame
36 weeks post menstrual age2
Number of Patients with Retinopathy of prematurity
Time frame
36 weeks post menstrual age3
Number of Patients with Sepsis
Time frame
36 weeks post menstrual age4
Number of Patients with Necrotizing enterocolitis
Time frame
36 weeks post menstrual ageSponsors and contacts
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Source ClinicalTrials.gov