An interventional study of Preterm Infant Formula in Preterm Birth and Nutrition, Healthy, sponsored by Augusta University. Recruiting at 1 site in United States. Open to participants aged 28 Days and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Augusta University · Not applicable, Interventional, and Treatment
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 20 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Preterm Infant Formula
Transition from donor human milk to preterm infant formula
Weight Velocity
Weight velocity between birth and 36 weeks post menstrual age
Time frame: 36 weeks post menstrual age
Fat free mass
Fat free mass at 36 weeks post menstrual age
Time frame: 36 weeks post menstrual age
Number of Patients with Bronchopulmonary dysplasia
Time frame: 36 weeks post menstrual age
Number of Patients with Retinopathy of prematurity
Time frame: 36 weeks post menstrual age
Number of Patients with Sepsis
Time frame: 36 weeks post menstrual age
Number of Patients with Necrotizing enterocolitis
Time frame: 36 weeks post menstrual age
Plan to share: No
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