Electrogastrography in Small for Gestational Age Preterm... | NCT00819715

Studies
Electrogastrography in Small for Gestational Age Preterm Infants

NCT00819715

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

Oct 13, 2010Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Premature Birth

Interventions

Not provided

Countries

Israel

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

Jun 2009

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

Jun 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Not provided

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 9, 2009Estimated

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

Oct 10, 2010

Last Update Posted Date

Oct 13, 2010Estimated

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 determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Small for gestational age preterm infants
2		Appropriate for gestational preterm infants

Interventions

Not provided

Measure	Description	Time Frame
EGG compatible with age		day 1 and day 7 after birth

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

preterm infants 32-37 weeks' gestation
No sepsis or ventilation
Feeding orally or with NG tube.
Age <48 h to be included

Exclusion Criteria:

GE reflux
Medication that affect gastric motility

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

2 Days

Standard Ages

Child

Study Population

Preterm infants >31 weeks, - 37 weeks , healthy, on enteralfeeds

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shmuel Arnon, MD	Meir Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatal Department,Meir Medical Center		Kfar Saba		44281	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9530151	Result	Liang J, Co E, Zhang M, Pineda J, Chen JD. Development of gastric slow waves in preterm infants measured by electrogastrography. Am J Physiol. 1998 Mar;274(3):G503-8. doi: 10.1152/ajpgi.1998.274.3.G503.

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