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

Nestlé

Status

Completed

Conditions

Weight Gain

Treatments

Combination Product: Protein fortifier

Study type

Interventional

Funder types

Industry

Identifiers

NCT03604042

13.01.INF

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

23 to 32 weeks old

Volunteers

No Healthy Volunteers

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