Feeding Study in VLBW Premature Infants

Not Applicable

Terminated

• Conditions: VLBW - Very Low Birth Weight Infant
• Interventions: Other: Exempt Infant Formula

• Registration Number: NCT05744193
• Lead Sponsor: Mead Johnson Nutrition

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-24
• Study Start: 2023-07-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercial Liquid Human Milk Fortifier	Exempt Infant Formula	Liquid human milk fortifier to be added to human milk
Liquid Human Milk Fortifier - Standard Protein	Exempt Infant Formula	Liquid human milk fortifier to be added to human milk
Liquid Human Milk Fortifier - High Protein	Exempt Infant Formula	Liquid human milk fortifier to be added to human milk

Primary Outcome Measures

Name	Time	Method
Weight gain	Daily for 28 days	grams/kg/day

Secondary Outcome Measures

Name	Time	Method
Total protein intake	28 days	grams
Feeding Tolerance	Daily for 28 days	Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume)
Metabolic Acidosis	Study days 0, 14, 28	If CO2 \<18 mmol/L then Blood gas; Acidity (pH), Carbon dioxide, partial pressure (pCO2; torr), Bicarbonate (mmol/L); Base Excess (mmol/L)
Rate of Length and head circumference gain	weekly up to day 28	cm/week
Total energy intake	28 days	kcal
Respiratory status	28 days	Incidence of Apnea, Bradycardia, Supplemental oxygen/Continuous positive airway pressure/Nasal cannulation, Mechanical ventilation
Incidence of sepsis - culture for pathogens	Study day 0 through 28	Culture for pathogens - no culture, culture-negative, culture-positive, presumed contaminant
Incidence of sepsis - Antibiotic use	Study Day 0 through 28	Antibiotic use duration - less than 5 days ; 5 days or more
Incidence of NEC	Study Day 0 through 28	Modified Bell's Staging Criteria
Incidence of sepsis - clinical symptoms	Study Day 0 through 28	Clinical symptoms - Changes in respiration, blood pressure, body temperature, stool, blood sugar and heart rate
Total serum CO2	Study days 0, 14, 28	less than 18 mmol/L

Trial Locations

Locations (6)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

NYU Langone Hospital, Long Island; 🇺🇸 Mineola, New York, United States

Cohen Children's Medical Center of NY; 🇺🇸 New Hyde Park, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States