Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants

Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier

The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.

Inclusion Criteria:

• Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days.
• Birth weight less or equal to 1500 g
• Minimum enteral intake of 150-160 mL/kg/d fortified HM
• Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry

Exclusion Criteria:

• Infants with weight z-score < -2 SD, based on the Fenton growth chart (Fenton 2013)

• Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia.

• Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine.

• Cholestasis (total bilirubin > 5 mg/dL or 85 umol/L and direct bilirubin > 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT).

• Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.).

• Suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.).

• Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g.,:

  • NEC grade above or equal to 2
  • Uncontrolled sepsis

• Suspected or documented maternal substance abuse:

  • Born to mothers who smoked > 10 cigarettes per day during pregnancy
  • Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (> 3 alcoholic beverages per week) during pregnancy

• Subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol

• Infants who have received any experimental treatment or received any other investigational intervention (procedure or product) unrelated to this trial, prior to enrollment