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CompletedNCT00311142Updated Apr 16, 2008

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

An observational study in Healthy, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 1 Day to 2 Days. Per ClinicalTrials.gov, last updated 2008-04-16.

Sponsored by Sheba Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
1 Day to 2 Days
Sex
All
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Study 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.

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Conditions studied

  • Healthy

Keywords

  • Sleep pattern
  • newborn
  • actigraphy
  • delivery mode
  • Parents' approval
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In context

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 2 Days
Sexes eligible
All

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
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Study locations

1 site
  • Sheba Medical Center
    Ramat Gan, Israel
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References and documents

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. doi: 10.1081/cbi-120027980. PubMed 15129826 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00311142
Lead sponsor
Sheba Medical Center
First posted
Apr 5, 2006
Start date
Mar 2003
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Apr 16, 2008

Study contacts

Ayala Maayan-Metzger, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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