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