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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00311142
First received: April 4, 2006
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

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:

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

Keywords provided by Sheba Medical Center:
Sleep pattern
newborn
actigraphy
 delivery mode
Parents' approval
Newborn

ClinicalTrials.gov processed this record on May 23, 2013