Clinical trial NCT01766011: Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
Official title: Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre-term Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 28
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight gain per day
timeFrame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Secondary outcomes:
measure: Length
timeFrame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
measure: Daily Stool Questionnaire
timeFrame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
measure: Serum Calcium
timeFrame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
measure: Head circumference
timeFrame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
measure: Daily Feeding Questionnaire
timeFrame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
measure: Any periods of nil per os (NPO)
timeFrame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
measure: Phosphorus
timeFrame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
measure: Alkaline Phosphatase
timeFrame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama - Children's and Women's Hospital
state: Alabama
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Valhalla
country: United States
facility: Maria Children's Hospital Westchester Medical Center
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare-St. Joseph
state: Wisconsin
Study officials:
affiliation: Abbott Nutrition
name: Bridget Barrett Reis, PhD, RD, LD
role: STUDY_CHAIR
References: