NCT00311142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 16, 2008

Status Verified

April 1, 2008

Enrollment Period

4.1 years

First QC Date

April 4, 2006

Last Update Submit

April 15, 2008

Conditions

Healthy

Keywords

Sleep patternnewbornactigraphydelivery modeParents' approval

Eligibility Criteria

Age1 Day - 2 Days
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related 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. doi: 10.1081/cbi-120027980.

    PMID: 15129826BACKGROUND

Study Officials

  • Ayala Maayan-Metzger, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 5, 2006

Study Start

March 1, 2003

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 16, 2008

Record last verified: 2008-04

Locations

IL(1)