Feeding Study in VLBW Premature Infants

Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)

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

Study Overview

• Status: Terminated
• Conditions: VLBW - Very Low Birth Weight Infant
• Intervention / Treatment: Other: Exempt Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Hospital
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital, Long Island
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center of NY
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Commercial Liquid Human Milk Fortifier; Liquid human milk fortifier to be added to human milk	Other: Exempt Infant Formula; Liquid human milk fortifier to be added to human milk daily
Experimental: Liquid Human Milk Fortifier - Standard Protein; Liquid human milk fortifier to be added to human milk	Other: Exempt Infant Formula; Liquid human milk fortifier to be added to human milk daily
Experimental: Liquid Human Milk Fortifier - High Protein; Liquid human milk fortifier to be added to human milk	Other: Exempt Infant Formula; Liquid human milk fortifier to be added to human milk daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain	grams/kg/day	Daily for 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Tolerance	Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)	Daily for 28 days
Rate of Length and head circumference gain	cm/week	weekly up to day 28
Total energy intake	kcal	28 days
Total protein intake	grams	28 days
Respiratory status	Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation	28 days
Incidence of NEC	Modified Bell's Staging Criteria	Study Day 0 through 28
Incidence of sepsis - clinical symptoms	Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate	Study Day 0 through 28
Incidence of sepsis - culture for pathogens	Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant	Study day 0 through 28
Incidence of sepsis - Antibiotic use	Antibiotic use duration - less than 5 days ; 5 days or more	Study Day 0 through 28
Total serum CO2	less than 18 mmol/L	Study days 0, 14, 28
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)	Study days 0, 14, 28

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 3394-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No