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Feeding Study in VLBW Premature Infants

Primary Purpose

VLBW - Very Low Birth Weight Infant

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exempt Infant Formula
Sponsored by
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for VLBW - Very Low Birth Weight Infant

Eligibility Criteria

168 Days - 224 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinically and metabolically stable Birth weight 700 g to less than or equal to 1,250 g Appropriate birth weight for gestational age 24 0/7 to 32 0/7 weeks' gestational age at birth Exclusively fed human milk Signed informed consent and authorization to use and/or disclose PHI Exclusion Criteria: Metabolic or chronic disease 5-minute Apgar score <4 Major surgery Ventilator dependent Fluid restriction Grade III or IV intraventricular hemorrhage (IVH)

Sites / Locations

  • The University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Commercial Liquid Human Milk Fortifier

Liquid Human Milk Fortifier - Standard Protein

Liquid Human Milk Fortifier - High Protein

Arm Description

Liquid human milk fortifier to be added to human milk

Liquid human milk fortifier to be added to human milk

Liquid human milk fortifier to be added to human milk

Outcomes

Primary Outcome Measures

Weight gain
grams/kg/day

Secondary Outcome Measures

Feeding Tolerance
Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)
Rate of Length and head circumference gain
cm/week
Total energy intake
kcal
Total protein intake
grams
Respiratory status
Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation
Incidence of NEC
Modified Bell's Staging Criteria
Incidence of sepsis - clinical symptoms
Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate
Incidence of sepsis - culture for pathogens
Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant
Incidence of sepsis - Antibiotic use
Antibiotic use duration - less than 5 days ; 5 days or more
Total serum CO2
less than 18 mmol/L
Metabolic Acidosis
If CO2 <18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L)

Full Information

First Posted
January 31, 2023
Last Updated
May 1, 2023
Sponsor
Mead Johnson Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT05744193
Brief Title
Feeding Study in VLBW Premature Infants
Official Title
Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
VLBW - Very Low Birth Weight Infant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
369 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Commercial Liquid Human Milk Fortifier
Arm Type
Active Comparator
Arm Description
Liquid human milk fortifier to be added to human milk
Arm Title
Liquid Human Milk Fortifier - Standard Protein
Arm Type
Experimental
Arm Description
Liquid human milk fortifier to be added to human milk
Arm Title
Liquid Human Milk Fortifier - High Protein
Arm Type
Experimental
Arm Description
Liquid human milk fortifier to be added to human milk
Intervention Type
Other
Intervention Name(s)
Exempt Infant Formula
Intervention Description
Liquid human milk fortifier to be added to human milk daily
Primary Outcome Measure Information:
Title
Weight gain
Description
grams/kg/day
Time Frame
Daily for 28 days
Secondary Outcome Measure Information:
Title
Feeding Tolerance
Description
Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)
Time Frame
Daily for 28 days
Title
Rate of Length and head circumference gain
Description
cm/week
Time Frame
weekly up to day 28
Title
Total energy intake
Description
kcal
Time Frame
28 days
Title
Total protein intake
Description
grams
Time Frame
28 days
Title
Respiratory status
Description
Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation
Time Frame
28 days
Title
Incidence of NEC
Description
Modified Bell's Staging Criteria
Time Frame
Study Day 0 through 28
Title
Incidence of sepsis - clinical symptoms
Description
Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate
Time Frame
Study Day 0 through 28
Title
Incidence of sepsis - culture for pathogens
Description
Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant
Time Frame
Study day 0 through 28
Title
Incidence of sepsis - Antibiotic use
Description
Antibiotic use duration - less than 5 days ; 5 days or more
Time Frame
Study Day 0 through 28
Title
Total serum CO2
Description
less than 18 mmol/L
Time Frame
Study days 0, 14, 28
Title
Metabolic Acidosis
Description
If CO2 <18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L)
Time Frame
Study days 0, 14, 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
168 Days
Maximum Age & Unit of Time
224 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically and metabolically stable Birth weight 700 g to less than or equal to 1,250 g Appropriate birth weight for gestational age 24 0/7 to 32 0/7 weeks' gestational age at birth Exclusively fed human milk Signed informed consent and authorization to use and/or disclose PHI Exclusion Criteria: Metabolic or chronic disease 5-minute Apgar score <4 Major surgery Ventilator dependent Fluid restriction Grade III or IV intraventricular hemorrhage (IVH)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Moore, RD
Phone
812-429-5000
Email
nancy.moore@reckitt.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Gates, RD PhD
Phone
706-799-9598
Email
amy.gates@reckitt.com
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salas, MD
Phone
205-934-4680

12. IPD Sharing Statement

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Feeding Study in VLBW Premature Infants

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