HypothermiaNCT01018576
Delayed Cord Clamping in Premature Infants
A study testing Delayed cord clamping in people with Hypothermia and Anemia, run by University of California, Davis at 1 site in United States.
Trial summary
Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Hypothermia, Anemia
- What is being tested?
- Delayed cord clamping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2012
- Phase
- Interventional
- 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 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature infants at 24-28 completed weeks gestation at the time of delivery
- informed consent obtained from parents prior to delivery
Who cannot join
- multiple gestation (twins, triplets, etc)
- prolonged fetal bradycardia
- placental abruption or previa
- maternal illness
- major congenital anomalies
- maternal fever in labor
- fetal illness (e.g. isoimmune hemolysis)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants
Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.
Read the detailed description
Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.
- Conditions
- Hypothermia, Anemia
- Being tested
- Delayed cord clamping
- Keywords
- delayed cord clamping, premature infants, hypothermia, anemia, intraventricular hemorrhage, Anemia in premature infants
- Medical subject headings
- Hypothermia, Anemia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingOther
Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Delayed cord clamping | Experimental | Not described Receives: Other: Delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial body temperature
Measured: At birth
Secondary outcomes (1)
Hematocrit at birth and 24 hours of age
Measured: first day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionMar 2012
Why it stopped: Inadequate numbers of babies enrolled and departure of co-investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Underwood, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018576
- Sponsor's protocol ID
- 200916964
- Status last verified
- Dec 2014
- First submitted
- 5 Nov 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants
- ClinicalTrials.gov ID
- NCT01018576
- Acronym / sponsor ID
- 200916964
- Conditions
- Hypothermia, Anemia
- Keywords
- delayed cord clamping, premature infants, hypothermia, anemia, intraventricular hemorrhage, Anemia in premature infants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate numbers of babies enrolled and departure of co-investigator
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Nov 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.
Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.
Detailed description
Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delayed cord clamping | Experimental | Other: Delayed cord clamping |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- premature infants at 24-28 completed weeks gestation at the time of delivery
- informed consent obtained from parents prior to delivery
Key exclusion criteria (7 listed)
- multiple gestation (twins, triplets, etc)
- prolonged fetal bradycardia
- placental abruption or previa
- maternal illness
- major congenital anomalies
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 |
|---|---|---|
| Delayed cord clampingInfants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds. | Other | Delayed cord clamping |
Primary outcome
Initial body temperature
Time frame: At birth
1 secondary outcome
Hematocrit at birth and 24 hours of age
Time frame: first day of life
Results and safety
The study was stopped early (reason given: Inadequate numbers of babies enrolled and departure of co-investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Mark A Underwood, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping in people with Hypothermia and Anemia, run by University of California, Davis at 1 site in United States.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Dec 2014. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Inadequate numbers of babies enrolled and departure of co-investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial body temperature (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2014; AzTrials last refreshed its copy on 4 Nov 2026.