Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
- Conditions
- Pre-term Infants
- Interventions
- Other: study pre-term formula
- Registration Number
- NCT01766011
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study pre-term formula study pre-term formula Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Alkaline Phosphatase SDAY 1, 15, and 29 or hospital discharge (whichever comes first) Blood biochemistries
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
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.
Phosphorus SDAY 1, 15, and 29 or hospital discharge (whichever comes first) Blood biochemistries
Trial Locations
- Locations (7)
University of South Alabama - Children's and Women's Hospital
🇺🇸Mobile, Alabama, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Maria Children's Hospital Westchester Medical Center
🇺🇸Valhalla, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Wheaton Franciscan Healthcare-St. Joseph
🇺🇸Milwaukee, Wisconsin, United States