Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01766011
First received: January 8, 2013
Last updated: March 2, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Pre-term Infants
Other: study pre-term formula
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight gain per day [ Time Frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first ] [ Designated as safety issue: No ]
    weight gain per day (g/kg/d)


Secondary Outcome Measures:
  • Length [ Time Frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first ] [ Designated as safety issue: No ]
    Growth, change in length

  • Daily Stool Questionnaire [ Time Frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first ] [ Designated as safety issue: No ]
    Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured.

  • Serum Calcium [ Time Frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first) ] [ Designated as safety issue: No ]
    Blood biochemistries

  • Head circumference [ Time Frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first ] [ Designated as safety issue: No ]
    Growth, change in head circumference

  • Daily Feeding Questionnaire [ Time Frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first ] [ Designated as safety issue: No ]
    Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured.

  • Any periods of nil per os (NPO) [ Time Frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first ] [ Designated as safety issue: No ]
    Gastro-Intestinal Tolerance

  • Phosphorus [ Time Frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first) ] [ Designated as safety issue: No ]
    Blood biochemistries

  • Alkaline Phosphatase [ Time Frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first) ] [ Designated as safety issue: No ]
    Blood biochemistries


Enrollment: 28
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study pre-term formula
Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles
Other: study pre-term formula
24 kcal/fl oz pre-term formula for in-hospital use
Other Name: Similac Special Care

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766011

Locations
United States, Alabama
University of South Alabama - Children's and Women's Hospital
Mobile, Alabama, United States, 36604
United States, Indiana
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, New York
Maria Children's Hospital Westchester Medical Center
Valhalla, New York, United States, 10595
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Wisconsin
Wheaton Franciscan Healthcare-St. Joseph
Milwaukee, Wisconsin, United States, 53210
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Bridget Barrett Reis, PhD, RD, LD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01766011     History of Changes
Other Study ID Numbers: AL01
Study First Received: January 8, 2013
Last Updated: March 2, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 03, 2015