Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year - Full Text View

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

This study is not yet open for participant recruitment.
Verified by Sheba Medical Center, December 2007

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00550069

Purpose

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.

Condition

Respiratory Distress
Hypoglycemia
Feeding Intolerance
Jaundice
Hypothermia
Developmental Delay

MedlinePlus related topics:

Hypoglycemia Hypothermia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2009

Detailed Description:

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

Eligibility

Ages Eligible for Study:	up to 30 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No chromosomal abnormalities
Malformations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550069

Contacts


Contact: Iris Morag, MD	+972-52-666-7393	irismorag@gmail.com

Contact: Lidia Gavis, MD	052-666-7360	lidia.gavis@health.gov.il

Locations


Israel
	Sheba Medical Center	Not yet recruiting
	Tel Hashomer, Israel, 52621
	Principal Investigator: Iris Morag, MD

Sponsors and Collaborators

Sheba Medical Center

Investigators


Principal Investigator:	Iris Morag, M.D	Sheba Medical Center

More Information

Responsible Party:	Sheba Medical Cener ( Dr. Iris Morag )
Study ID Numbers:	SHEBA-07-4821-IM-CTIL
First Received:	October 25, 2007
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00550069
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

late preterm infants

near term infants

outcome

Study placed in the following topic categories:

Signs and Symptoms

Hypothermia

Metabolic Diseases

Hyperbilirubinemia

Metabolic disorder

Glucose Metabolism Disorders

Hypoglycemia

Jaundice

Additional relevant MeSH terms:

Skin Manifestations

Pathologic Processes

Body Temperature Changes

ClinicalTrials.gov processed this record on October 17, 2008