Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section

This study has been completed.

First Received: April 4, 2006 Last Updated: April 15, 2008 History of Changes

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00311142

Purpose

The development of regular sleep-wake cycle is an important factor of the newborn maturation and it has influence on behavior .Factor that may influence the process of the maturation of the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected and measured with actigraphy, using a wrist-watch like device that continuously measures and records the subject's movements.The present study aims to compare vacuum delivery with regular, elective and not elective caesarean sections. We hypothesize that the sleep of vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.

Condition
Healthy

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section.

Further study details as provided by Sheba Medical Center:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	24
Study Start Date:	March 2003
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 2 Days
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Healthy newborn, born either by regular delivery, vacuum extraction or cesarean section

Exclusion Criteria:

Preterms, newborns that need special medical treatment and/or repeated blood sampling as glucose.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311142

Locations

Israel
Sheba Medical Center
Ramat Gan, Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

Ayala Maayan-Metzger, MD

Sheba Medical Center

More Information

Publications:

Korte J, Hoehn T, Siegmund R. Actigraphic recordings of activity-rest rhythms of neonates born by different delivery modes. Chronobiol Int. 2004 Jan;21(1):95-106.

Responsible Party:	Sheba Medical Center ( Dr. Ayala Maayan )
Study ID Numbers:	SHEBA-06-3126-AM-CTIL
Study First Received:	April 4, 2006
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00311142 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Sleep pattern
newborn
actigraphy

delivery mode
Parents' approval
Newborn

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009