Clinical trial NCT03604042: Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants
Official title: Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 68
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of weight gain
timeFrame: From Day 6 to Day 27
Secondary outcomes:
measure: Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard Human Milk (HM) fortification
timeFrame: Day 6 to Day 13, and Day 6 to Day 27
measure: Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
timeFrame: Day 6 to Day 27 (minimum)
measure: Changes in growth parameters: head circumference and head circumference gain (cm)
timeFrame: Day 6 to Day 27 (minimum)
measure: Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)
timeFrame: Day 6 to Day 27 (minimum)
measure: Body composition including lean fat mass and fat-free mass
timeFrame: Day 6 to Day 27 (minimum)
measure: Weight at hospital discharge
timeFrame: Day 27 (minimum)
measure: Macronutrient content in human milk
timeFrame: Day 6 to Day 27 (minimum)
measure: Feeding and gastrointestinal (GI) tolerance
timeFrame: Day 6 to Day 27 (minimum)
measure: Safety evaluation including number of subjects with AEs
timeFrame: Day 1 to Day 27 (minimum)
measure: Biochemistry markers collected from blood and urine as part of routine NICU standard of care
timeFrame: Day 6 to Day 27 (minimum)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix Rousse
Study officials:
affiliation: Nestlé Research
name: Sebastien Paoli, Msc
role: STUDY_CHAIR
References: