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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Abbott Nutrition
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01766011
First received: January 8, 2013
Last updated: January 25, 2013
Last verified: January 2013
  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


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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

Contacts
Contact: Kristen DeLuca, MS, RD 614 624 5455 kristen.deluca@abbott.com
Contact: Bobbie Swearengin, RN 614 624 7182 bobbie.swearengin@abbott.com

Locations
United States, Alabama
University of South Alabama - Children's and Women's Hospital Not yet recruiting
Mobile, Alabama, United States, 36604
Principal Investigator: Fabien Eyal, MD         
United States, Indiana
Memorial Hospital of South Bend Not yet recruiting
South Bend, Indiana, United States, 46601
Principal Investigator: Robert White, MD         
United States, Kansas
Wesley Medical Center Not yet recruiting
Wichita, Kansas, United States, 67214
Principal Investigator: Barry Bloom, MD         
United States, New York
Maria Children's Hospital Westchester Medical Center Not yet recruiting
Valhalla, New York, United States, 10595
Principal Investigator: Lance Parton, MD         
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Sharon Groh-Wargo, PhD         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Principal Investigator: Anthony Killian, MD         
United States, Wisconsin
Wheaton Franciscan Healthcare-St. Joseph Not yet recruiting
Milwaukee, Wisconsin, United States, 53210
Principal Investigator: Jeffery Garland, MD         
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: January 25, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014