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

NCT03604042 | Completed DMC

• 1 other identifier: 13.01.INF
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)

  Day 6 to Day 27 (minimum)

• Changes in growth parameters: head circumference and head circumference gain (cm)

  Day 6 to Day 27 (minimum)

• Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)

  Day 6 to Day 27 (minimum)

• Body composition including lean fat mass and fat-free mass

  Day 6 to Day 27 (minimum)

Study Arms (2)

Weight-driven protein fortification

ACTIVE COMPARATOR

Individualized protein fortification based on weight gain

Combination Product: Protein fortifier

BUN-driven protein fortification

EXPERIMENTAL

Individualized protein fortification based on BUN concentrations

Combination Product: Protein fortifier

Interventions

Protein fortifier COMBINATION_PRODUCT

Protein Fortifier to be added to Fortified human milk according to feeding regimen

BUN-driven protein fortification; Weight-driven protein fortification

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Hopital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastien Paoli, Msc

  Nestlé Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: July 27, 2018
• Study Start: October 9, 2017
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

FR (1)