VLBW - Very Low Birth Weight Infant
Conditions
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
Interventions
OTHERExempt Infant Formula
Liquid human milk fortifier to be added to human milk daily
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
168 Days to 224 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | Daily for 28 days | grams/kg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total protein intake | 28 days | grams |
| 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 NEC | Study Day 0 through 28 | Modified Bell's Staging Criteria |
| Feeding Tolerance | Daily for 28 days | Achievement of full enteral feeding, incidence of (TPN, Bloody stools, Feeding interruptions, Drop in feeding volume) |
| 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 |
| Total serum CO2 | Study days 0, 14, 28 | less than 18 mmol/L |
| 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) |
| 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 |
Countries
United States
Outcome results
None listed