Feeding Study in VLBW Premature Infants

VLBW - Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05744193
• Other study ID #: 3394-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Mead Johnson Nutrition
• Contact: Nancy Moore, RD
• Phone: 812-429-5000
• Email: nancy.moore[@]reckitt.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 369
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 168 Days to 224 Days

Eligibility

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)

Related Conditions & MeSH terms

• Birth Weight
• VLBW - Very Low Birth Weight Infant

Intervention

Other:
• Exempt Infant Formula
Liquid human milk fortifier to be added to human milk daily

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

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