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

Primary Purpose

Weight Gain

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Protein fortifier

About this trial

This is an interventional other trial for Weight Gain

Eligibility Criteria

23 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital de la Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight-driven protein fortification

BUN-driven protein fortification

Arm Description

Individualized protein fortification based on weight gain

Individualized protein fortification based on BUN concentrations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Body composition including lean fat mass and fat-free mass

Weight at hospital discharge

Macronutrient content in human milk

Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk

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

Safety evaluation including number of subjects with AEs

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

Full Information

NCT ID

NCT03604042

First Posted

April 26, 2018

Last Updated

March 5, 2020

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT03604042

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 9, 2017 (Actual)

Primary Completion Date

February 10, 2020 (Actual)

Study Completion Date

February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Gain

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight-driven protein fortification

Arm Type

Active Comparator

Arm Description

Individualized protein fortification based on weight gain

Arm Title

BUN-driven protein fortification

Arm Type

Experimental

Arm Description

Individualized protein fortification based on BUN concentrations

Intervention Type

Combination Product

Intervention Name(s)

Protein fortifier

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of weight gain

Description

Time Frame

From Day 6 to Day 27

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 6 to Day 13, and Day 6 to Day 27

Title

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

Description

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

Time Frame

Day 6 to Day 27 (minimum)

Title

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

Description

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

Time Frame

Day 6 to Day 27 (minimum)

Title

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

Description

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

Time Frame

Day 6 to Day 27 (minimum)

Title

Body composition including lean fat mass and fat-free mass

Description

Body composition including lean fat mass and fat-free mass

Time Frame

Day 6 to Day 27 (minimum)

Title

Weight at hospital discharge

Description

Weight at hospital discharge

Time Frame

Day 27 (minimum)

Title

Macronutrient content in human milk

Description

Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk

Time Frame

Day 6 to Day 27 (minimum)

Title

Feeding and gastrointestinal (GI) tolerance

Description

Time Frame

Day 6 to Day 27 (minimum)

Title

Safety evaluation including number of subjects with AEs

Description

Safety evaluation including number of subjects with AEs

Time Frame

Day 1 to Day 27 (minimum)

Title

Biochemistry markers collected from blood and urine as part of routine NICU standard of care

Description

Time Frame

Day 6 to Day 27 (minimum)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

23 Weeks

Maximum Age & Unit of Time

32 Weeks

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sebastien Paoli, Msc

Organizational Affiliation

Nestlé Research

Official's Role

Study Chair

Facility Information:

Facility Name

Hopital de la Croix Rousse

City

Lyon

ZIP/Postal Code

69004

Country

France

12. IPD Sharing Statement

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

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