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

Not Applicable

Completed

• Conditions: Weight Gain
• Interventions: Combination Product: Protein fortifier

• Registration Number: NCT03604042
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-09
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight-driven protein fortification	Protein fortifier	Individualized protein fortification based on weight gain
BUN-driven protein fortification	Protein fortifier	Individualized protein fortification based on BUN concentrations

Primary Outcome Measures

Name	Time	Method
Comparison of weight gain	From Day 6 to Day 27	To compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a BUN-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen

Secondary Outcome Measures

Name	Time	Method
Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)	Day 6 to Day 27 (minimum)	Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
Body composition including lean fat mass and fat-free mass	Day 6 to Day 27 (minimum)	Body composition including lean fat mass and fat-free mass
Weight at hospital discharge	Day 27 (minimum)	Weight at hospital discharge
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	Day 6 to Day 13, and Day 6 to Day 27	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 HM fortification
Changes in growth parameters: head circumference and head circumference gain (cm)	Day 6 to Day 27 (minimum)	Changes in growth parameters: head circumference and head circumference gain (cm)
Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)	Day 6 to Day 27 (minimum)	Changes in growth parameters: BMI and BMI changes (kg body weight/m\^2)
Macronutrient content in human milk	Day 6 to Day 27 (minimum)	Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk
Feeding and gastrointestinal (GI) tolerance	Day 6 to Day 27 (minimum)	Feeding and gastrointestinal (GI) tolerance determined using Digestive tolerance scores based on four binary parameters (0 = absence or 1 = presence) collected in daily routine care: Sore abdomen, liquid stools, gastric residuals, and regurgitation or vomiting
Safety evaluation including number of subjects with AEs	Day 1 to Day 27 (minimum)	Safety evaluation including number of subjects with AEs
Biochemistry markers collected from blood and urine as part of routine NICU standard of care	Day 6 to Day 27 (minimum)	Biochemistry markers collected from blood and urine as part of routine NICU standard of care: Routine biochemistries in Blood/Serum and Urine (in spot urine samples), and Nutrition markers in Blood/serum: albumin, pre-albumin, alkaline phosphatase, triglycerides and vitamin D

Trial Locations

Locations (1)

Hopital de la Croix Rousse; 🇫🇷 Lyon, France