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

NCT ID: NCT00311142

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Sleep pattern newborn actigraphy delivery mode Parents' approval

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Ayala Maayan-Metzger, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 15129826 (View on PubMed)

Other Identifiers

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SHEBA-06-3126-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id