Nutritional Content of Breast Milk From Mothers of Premies | NCT01050192

Studies
Nutritional Content of Breast Milk From Mothers of Premies

NCT01050192

Sponsor

Pediatrix

Status

Withdrawn

Last Update Posted

Mar 23, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prematurity
Nutrition

Interventions

Not provided

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 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 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

Mar 21, 2017

Last Update Posted Date

Mar 23, 2017Actual

Name	Class
Prolacta Bioscience	INDUSTRY

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 determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period.		28 days of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers of infants with a gestational age <=30 weeks in the NICU who are supplying their own breast milk for use by their baby
Reasonable likelihood of survival of infant to 28 days
Infant on/ready for oral feeding by DOL 7 days
Willing to provide breast milk for their baby
Able to produce at least 7mL breast milk per feeding
Willing to abide by requirements of the study protocol
Documentation of informed consent

Exclusion Criteria:

Unable to provide at least 7mL breast milk per feeding
Medically unsuitable to provide breast milk to her baby
Maternal age <18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Weeks

Maximum Age

30 Weeks

Standard Ages

Child

Study Population

Neonatal Intensive Care Unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reese Clark, MD	Greenville Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Greenville Memorial Hospital		Greenville	South Carolina		United States

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D001942	Breast Feeding

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