Immediate VS Delayed Cord Clamping on Newborns
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ClinicalTrials.gov Identifier: NCT01029496 |
Recruitment Status
: Unknown
Verified September 2009 by Hainan Medical College.
Recruitment status was: Recruiting
First Posted
: December 10, 2009
Last Update Posted
: March 2, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | December 9, 2009 | |||
First Posted Date ICMJE | December 10, 2009 | |||
Last Update Posted Date | March 2, 2010 | |||
Study Start Date ICMJE | September 2009 | |||
Estimated Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
hemoglobin level of the baby 1 month after birth [ Time Frame: 2 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01029496 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
departure time of the umbilical cord [ Time Frame: 2 years ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Immediate VS Delayed Cord Clamping on Newborns | |||
Official Title ICMJE | Effect of Umbilical Cord Clamping Time on Newborns | |||
Brief Summary | The best time of the umbilical cord clamping has not been fully understood. immediate cord clamping (with in 10 seconds after birth) has been standardized practice for many years, while WHO protocol recommends to wait for 60-90 seconds. but the umbilical cord may still pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the time of umbilical cord will affect the newborn? will the longer time be less umbilical bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the cord after the pulsing ceased is the best time for cord clamping and will result in better quality of life for the newborn and less cord bleeding and earlier departure time of the cord, that means less infections of the cord. | |||
Detailed Description |
experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing. control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the Irradiation table. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Participant) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Procedure: different time of umbilical cord clamping
experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing. control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the Irradiation table. Other Name: DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING |
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Study Arms | Not Provided | |||
Publications * | zhang hong-yu,Meng li-ping,Xie chun-li.summary of current clinical protocols of umbilical cord care.Chinese journal of nurisng.3(43):275-277,2008 | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
120 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | June 2011 | |||
Estimated Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 6 Months (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01029496 | |||
Other Study ID Numbers ICMJE | hainanmc | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | huangyuanhua, hainan medical college | |||
Study Sponsor ICMJE | Hainan Medical College | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hainan Medical College | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |