Pre-term Infants
Conditions
Brief summary
The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.
Interventions
OTHERstudy pre-term formula
24 kcal/fl oz pre-term formula for in-hospital use
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
No
Inclusion criteria
* Subjects eligible for study participation will satisfy the following criteria: * Birth weight between 1000g -1800g * Less than or equal to 34 weeks and 0 days gestational age at birth * Appropriate for gestational age (AGA) * Singleton or twin births * Infant is 21 days of age or less
Exclusion criteria
* Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study: * Expected to be transferred to another facility within 14 days * Serious congenital abnormalities that may affect growth and development * Intubated for ventilation at the time of study product initiation * Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH) * Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy * Infant has a history of major surgery * Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia * Confirmed necrotizing enterocolitis or confirmed sepsis * Current use or planned use of probiotics * Participation in another study that has not been approved
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain per day | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | weight gain per day (g/kg/d) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Stool Questionnaire | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured. |
| Serum Calcium | SDAY 1, 15, and 29 or hospital discharge (whichever comes first) | Blood biochemistries |
| Head circumference | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | Growth, change in head circumference |
| Length | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | Growth, change in length |
| Any periods of nil per os (NPO) | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | Gastro-Intestinal Tolerance |
| Phosphorus | SDAY 1, 15, and 29 or hospital discharge (whichever comes first) | Blood biochemistries |
| Alkaline Phosphatase | SDAY 1, 15, and 29 or hospital discharge (whichever comes first) | Blood biochemistries |
| Daily Feeding Questionnaire | Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first | Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured. |
Countries
United States
Outcome results
None listed