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

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.

Study Overview

• Status: Completed
• Conditions: Pre-term Infants
• Intervention / Treatment: Other: study pre-term formula

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama - Children's and Women's Hospital
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
  • New York
    • Valhalla, New York, United States, 10595
      • Maria Children's Hospital Westchester Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • LeHigh Valley Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • Wheaton Franciscan Healthcare-St. Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Similac Special Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain per day	weight gain per day (g/kg/d)	Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length	Growth, change in length	Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Stool Questionnaire	Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured.	Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Serum Calcium	Blood biochemistries	SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Head circumference	Growth, change in head circumference	Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Daily Feeding Questionnaire	Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured.	Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Any periods of nil per os (NPO)	Gastro-Intestinal Tolerance	Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first
Phosphorus	Blood biochemistries	SDAY 1, 15, and 29 or hospital discharge (whichever comes first)
Alkaline Phosphatase	Blood biochemistries	SDAY 1, 15, and 29 or hospital discharge (whichever comes first)

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Bridget Barrett Reis, PhD, RD, LD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: AL01