NewbornPhase 1/2NCT01029496
Immediate VS Delayed Cord Clamping on Newborns
A Phase 1/2 study testing different time of umbilical cord clamping in people with Newborn and Umbilical Cord, run by Hainan Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Newborn, Umbilical Cord
- What is being tested?
- different time of umbilical cord clamping
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.
Who cannot join
- still birth
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hainan Medical College Appendix Hospital
Haikou, Hainan, 571101
zhang hong yu, master, 086-13158942317, hong1029@sohu.com
zhang hong yu, master
About this study
Official title: Effect of Umbilical Cord Clamping Time on Newborns
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.
Read the detailed description
- for normal newborn (apgar score over 7), regardless term or preterm,normal birth or cesarean section born: experimental group1: waiting for the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen. control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth.
- for in case of newborn asphyxia(regardless term or preterm,normal birth or cesarean section born): 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.
- Conditions
- Newborn, Umbilical Cord
- Being tested
- different time of umbilical cord clamping
- Keywords
- umbilical CORD CLAMPING, Neonatal anemia, Omphalitis
- Medical subject headings
- Anemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different time of umbilical cord clampingProcedure or surgery
Also called DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING
- for normal birth(apgar score over 7),include:term ,preterm,normal birth or cesarean section : experimental group1: waiting until the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen. control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth.
- for in case of asphyxia(regardless term or preterm,normal birth or cesarean section born): 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin level of the baby 1 month after birth
Measured: 2 years
Secondary outcomes (1)
departure time of the umbilical cord
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hainan Medical College
- Sponsor type
- University, hospital or other
- Investigators
- hua shao ping, professor, Study director, director of ob&gny dpt.of appendix hospital of hainan medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029496
- Sponsor's protocol ID
- hainanmc
- Status last verified
- Sep 2009
- First submitted
- 9 Dec 2009
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Umbilical Cord Clamping Time on Newborns
- ClinicalTrials.gov ID
- NCT01029496
- Acronym / sponsor ID
- hainanmc
- Conditions
- Newborn, Umbilical Cord
- Keywords
- umbilical CORD CLAMPING, Neonatal anemia, Omphalitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hainan Medical CollegeUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- for normal newborn (apgar score over 7), regardless term or preterm,normal birth or cesarean section born: experimental group1: waiting for the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen. control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth.
- for in case of newborn asphyxia(regardless term or preterm,normal birth or cesarean section born): 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.
Key exclusion criteria (1 listed)
- still birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different time of umbilical cord clampingAlso: DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING1. for normal birth(apgar score over 7),include:term ,preterm,normal birth or cesarean section : experimental group1: waiting until the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen. control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth. 2. for in case of asphyxia(regardless term or preterm,normal birth or cesarean section born): 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. | Procedure or surgery | – |
Primary outcome
hemoglobin level of the baby 1 month after birth
Time frame: 2 years
1 secondary outcome
departure time of the umbilical cord
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Backgroundzhang 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hua shao ping, professor study director
director of ob&gny dpt.of appendix hospital of hainan medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing different time of umbilical cord clamping in people with Newborn and Umbilical Cord, run by Hainan Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin level of the baby 1 month after birth (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.