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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604042
• Other study ID #: 13.01.INF
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Weight Gain

Intervention

Combination Product:
• Protein fortifier
Protein Fortifier to be added to Fortified human milk according to feeding regimen

Locations

Country	Name	City	State
France	Hopital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of weight gain	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	From Day 6 to Day 27
Secondary	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	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	Day 6 to Day 13, and Day 6 to Day 27
Secondary	Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)	Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)	Day 6 to Day 27 (minimum)
Secondary	Changes in growth parameters: head circumference and head circumference gain (cm)	Changes in growth parameters: head circumference and head circumference gain (cm)	Day 6 to Day 27 (minimum)
Secondary	Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)	Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)	Day 6 to Day 27 (minimum)
Secondary	Body composition including lean fat mass and fat-free mass	Body composition including lean fat mass and fat-free mass	Day 6 to Day 27 (minimum)
Secondary	Weight at hospital discharge	Weight at hospital discharge	Day 27 (minimum)
Secondary	Macronutrient content in human milk	Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk	Day 6 to Day 27 (minimum)
Secondary	Feeding and gastrointestinal (GI) tolerance	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	Day 6 to Day 27 (minimum)
Secondary	Safety evaluation including number of subjects with AEs	Safety evaluation including number of subjects with AEs	Day 1 to Day 27 (minimum)
Secondary	Biochemistry markers collected from blood and urine as part of routine NICU standard of care	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	Day 6 to Day 27 (minimum)