Observational Study of Infants Born at 34 to 37 Weeks of... | NCT00550069

Studies
Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year

NCT00550069

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Dec 27, 2007Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Respiratory Distress
Hypoglycemia
Feeding Intolerance
Jaundice
Hypothermia
Developmental Delay

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

Dec 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Not provided

Completion Date

Jan 2009Estimated

First Submitted Date

Oct 25, 2007

First Submission Date that Met QC Criteria

Oct 25, 2007

First Posted Date

Oct 26, 2007Estimated

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

Dec 24, 2007

Last Update Posted Date

Dec 27, 2007Estimated

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

Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one.

Detailed Description

The study will include all near term infants born at 3 Israeli medical centers during a one year period.

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

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age 34wks- 37wks
Singleton
Without chromosomal abnormalities or malformations

Exclusion Criteria:

No chromosomal abnormalities
Malformations

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

30 Days

Standard Ages

Child

Study Population

All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Iris Morag, MD	Contact	+972-52-666-7393		irismorag@gmail.com
Lidia Gavis, MD	Contact	052-666-7360		lidia.gavis@health.gov.il

Overall Officials

Name	Affiliation	Role
Iris Morag, M.D	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea
D007003	Hypoglycemia
D007565	Jaundice
D007035	Hypothermia
D007859	Learning Disabilities

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided