Preterm Infant Growth | NCT01162798

Studies
Preterm Infant Growth

NCT01162798

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 4, 2014Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Growth
Development
Infant

Interventions

infant formula
control infant formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jul 13, 2010

First Submission Date that Met QC Criteria

Jul 14, 2010

First Posted Date

Jul 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	commercially available formula	Other: control infant formula
Test	Experimental	test formula	Other: infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
infant formula	Other	test infant formula fed to infants until 6 months corrected gestational age	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Growth	weight gain assessed monthly	4 months

Secondary Outcomes

Measure	Description	Time Frame
growth, tolerance, morbidity	gains in length and head circumference assessed monthly, tolerance and morbidity throughout study	6 months
Total body bone mineral content and density and body composition, protein status, and metabolic markers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born AGA
Exclusively formula-fed
28-34 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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ekhard Ziegler, MD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital & Research Center		Oakland	California		United States
Advocate Lutheran Children's Hospital

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041943	Infant Formula

Ancestor Terms

ID	Term
D041941	Milk Substitutes
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided