Evaluation of a Standard Preterm Infant Formula Fed to Pr... | NCT01766011

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

NCT01766011

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

28Actual

Phase

Phase 2Phase 3

Conditions

Pre-term Infants

Interventions

study pre-term 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

Mar 2015

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

Nov 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 9, 2013

First Posted Date

Jan 11, 2013Estimated

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

Mar 2, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
study pre-term formula	Other	24 kcal/fl oz pre-term formula for in-hospital use	study pre-term formula

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided