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

NCT ID: NCT03604042

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2020-02-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Weight-driven protein fortification

Individualized protein fortification based on weight gain

Group Type: ACTIVE_COMPARATOR

Protein fortifier

Intervention Type: COMBINATION_PRODUCT

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

BUN-driven protein fortification

Individualized protein fortification based on BUN concentrations

Group Type: EXPERIMENTAL

Protein fortifier

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Protein fortifier

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

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastien Paoli, Msc

Role: STUDY_CHAIR

Nestlé Research

Locations

Hopital de la Croix Rousse

Lyon, , France

Countries

France

Other Identifiers

13.01.INF

Identifier Type: -

Identifier Source: org_study_id