NCT01162798

Brief Summary

The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

July 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

July 13, 2010

Last Update Submit

November 3, 2014

Conditions

GrowthDevelopmentInfant

Keywords

infant formulapremature infantsGrowth and Development

Outcome Measures

Primary Outcomes (1)

  • Growth

    weight gain assessed monthly

    4 months

Secondary Outcomes (2)

  • growth, tolerance, morbidity

    6 months

  • Total body bone mineral content and density and body composition, protein status, and metabolic markers

    corrected term and 4 months

Study Arms (2)

Control

ACTIVE COMPARATOR

commercially available formula

Other: control infant formula

Test

EXPERIMENTAL

test formula

Other: infant formula

Interventions

infant formulaOTHER

test infant formula fed to infants until 6 months corrected gestational age

Also known as: test infant formula
Test
control infant formulaOTHER

commercially available infant formula

Also known as: commercially available infant formula fed to infants until 6 months corrected gestational age
Control

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Born AGA
  • Exclusively formula-fed
  • weeks GA at birth
  • Intact GI tract, tolerating full oral feeds
  • Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

You may not qualify if:

  • Severe respiratory disease defined as needing mechanical ventilation at discharge
  • Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
  • Major congenital malformation, history of GI surgery, severe postnatal complications
  • Daily or routine diuretic use at time of discharge
  • Receiving more than 10% of daily kcals from food additives such as thickeners
  • Currently participating or having participated in another conflicting clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Children's Hospital & Research Center

Oakland, California, United States

Location

Advocate Lutheran Children's Hospital

Park Ridge, Illinois, United States

Location

University of Iowa

Iowa City, Iowa, 52241, United States

Location

Center for Human Nutrition

Omaha, Nebraska, 68105, United States

Location

Midatlantic Neonatology Associates, Inc

Morristown, New Jersey, 07962, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Utah, Dept of Pediatrics

Salt Lake City, Utah, 84108, United States

Location

VCU Children's Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Ekhard Ziegler, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 15, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Study Completion

September 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

US(9)