Premature BirthDUCNCT00562536
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks
A study testing Umbilical cord clamping in people with Premature Birth, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Umbilical cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Nov 2010
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
- Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).
Who cannot join
- Moderate to life threatening fetal anomalies
- Multiple live gestations at birth (e.g. twins, triplets, etc)
- Intrauterine fetal demise
- Previous participation
- Stem cell collection
Trial locations and contacts
1 site in 1 country.
Kelly Chu, MD contact
Canada1 site
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Kellie E. Murphy, MD MSc, 416 586-8570, kmurphy@mtsinai.on.ca
Kellie E. Murphy, MD MSc
About this study
Official title: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.
Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.
- Conditions
- Premature Birth
- Being tested
- Umbilical cord clamping
- Keywords
- Umbilical cord clamping, Preterm infants, Randomized controlled trial, For women giving birth to singleton infants 32 weeks gestational age or less
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord clampingProcedure or surgery
Delay of umbilical cord clamping 30 to 45 seconds
| Study group | Role | What they receive |
|---|---|---|
| A 1 | Experimental | Delayed umbilical cord clamping 30-45 seconds. Receives: Procedure: Umbilical cord clamping |
| A 2 | No intervention | Immediate umbilibcal cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Measured: 3 years
Secondary outcomes (1)
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startNov 2007
- Study completionNov 2010 (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 Premature BirthStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Kellie E Murphy, MD MSc, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562536
- Sponsor's protocol ID
- Mount Sinai Hospital Toronto
- Acronym
- DUC
- Status last verified
- Nov 2007
- First submitted
- 21 Nov 2007
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Chu KS, Shah PS, Whittle WL, Windrim R, Murphy KE. The "DUC" trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation. J Matern Fetal Neonatal Med. 2021 Dec;34(24):4049-4052. doi: 10.1080/14767058.2019.1702959. Epub 2019 Dec 25.
PubMed 31875737
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00562536
- Acronym / sponsor ID
- DUC / Mount Sinai Hospital Toronto
- Conditions
- Premature Birth
- Keywords
- Umbilical cord clamping, Preterm infants, Randomized controlled trial, For women giving birth to singleton infants 32 weeks gestational age or less
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Nov 2010 (estimated)
- First posted
- 22 Nov 2007 (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 overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.
Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 1 | Experimental | Procedure: Umbilical cord clampingDelayed umbilical cord clamping 30-45 seconds. |
| A 2 | No intervention | –Immediate umbilibcal cord clamping |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
- Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).
Key exclusion criteria (5 listed)
- Moderate to life threatening fetal anomalies
- Multiple live gestations at birth (e.g. twins, triplets, etc)
- Intrauterine fetal demise
- Previous participation
- Stem cell collection
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 |
|---|---|---|
| Umbilical cord clampingDelay of umbilical cord clamping 30 to 45 seconds | Procedure or surgery | A 1 |
Primary outcome
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Time frame: 3 years
1 secondary outcome
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
- Derived from this study: PubMed 31875737Chu KS, Shah PS, Whittle WL, Windrim R, Murphy KE. The "DUC" trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation. J Matern Fetal Neonatal Med. 2021 Dec;34(24):4049-4052. doi: 10.1080/14767058.2019.1702959. Epub 2019 Dec 25.
Related trials for Premature Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Kelly Chu, MD contact
Kellie E Murphy, MD MSc principal investigator
Mount Sinai Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord clamping in people with Premature Birth, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 5 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 22 Nov 2007. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kellie E. Murphy, MD MSc (416 586-8570, kmurphy@mtsinai.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis (time frame: 3 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 NCT00562536, 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 22 Nov 2007.