NCT01766011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

January 8, 2013

Last Update Submit

March 2, 2015

Conditions

Pre-term Infants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Length

    Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

  • Daily Stool Questionnaire

    Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

  • Serum Calcium

    SDAY 1, 15, and 29 or hospital discharge (whichever comes first)

  • Head circumference

    Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

  • Daily Feeding Questionnaire

    Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

  • +3 more secondary outcomes

Study Arms (1)

study pre-term formula

EXPERIMENTAL

Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles

Other: study pre-term formula

Interventions

study pre-term formulaOTHER

24 kcal/fl oz pre-term formula for in-hospital use

Also known as: Similac Special Care
study pre-term formula

Eligibility Criteria

AgeUp to 21 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of South Alabama - Children's and Women's Hospital

Mobile, Alabama, 36604, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Maria Children's Hospital Westchester Medical Center

Valhalla, New York, 10595, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Wheaton Franciscan Healthcare-St. Joseph

Milwaukee, Wisconsin, 53210, United States

Location

Study Officials

  • Bridget Barrett Reis, PhD, RD, LD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 11, 2013

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

US(7)