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NCT00311142 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311142
Other study ID # SHEBA-06-3126-AM-CTIL
Secondary ID
Status Completed
Phase N/A
First received April 4, 2006
Last updated April 15, 2008
Start date March 2003
Est. completion date April 2007

Study information
Verified date April 2008
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers
Gender Both
Age group N/A to 2 Days
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

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