Very Low Birth Weight InfantsDCCNCT02337088
Delayed Cord Clamping in Very Low Birth Weight Infants
A study testing Delayed cord clamping at 30 seconds and Delayed cord clamping at 60 seconds in people with Very Low Birth Weight Infants and Premature Infants, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Very Low Birth Weight Infants, Premature Infants, Intraventricular Hemorrhage
- What is being tested?
- Delayed cord clamping at 30 seconds and Delayed cord clamping at 60 seconds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2015to 28 Aug 2017
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who are expected to deliver a very low birth weight infant
- Neonates born weighing >= 500g and <1500 grams
- Mother 18 years of age or older
- English speaking mother
Who cannot join
- Placental abruption
- Vasa previa
- Fetal hydrops or other signs of fetal volume overload
- Other major fetal anomalies
- Placenta Accreta
- Mother < 18 years of age
- Non-English speaking mother
- Infants >= 1500g (3.3 lbs) or <500g
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
Read the detailed description
Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood.
Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping.
Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.
- Being tested
- Delayed cord clamping at 30 seconds, Delayed cord clamping at 60 seconds
- Keywords
- delayed cord clamping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clamping at 30 secondsProcedure or surgery
For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
Delayed cord clamping at 60 secondsProcedure or surgery
For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery
| Study group | Role | What they receive |
|---|---|---|
| 30 seconds | Active comparator | For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery. Receives: Procedure: Delayed cord clamping at 30 seconds |
| 60 seconds | Experimental | For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery. Receives: Procedure: Delayed cord clamping at 60 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraventricular hemorrhage
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
Measured: During NICU admission up to 6 months
Secondary outcomes (4)
Hemoglobin and hematocrit
Neonates will be followed for up to 6-months and initial H/H will be recorded.
Measured: During NICU admission up to 6 months
Need for blood transfusion
Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.
Measured: During NICU admission up to 6 months
Bilirubin levels
Neonates will be followed for up to 6-months and assessed for clinical jaundice.
Measured: During NICU admission up to 6 months
Delivery room temperature
Neonates will be assessed for hypothermia at the time of delivery.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start16 Apr 2015
- Primary completion17 May 2017
- Study completion28 Aug 2017
Why it stopped: Logistical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337088
- Sponsor's protocol ID
- 14-0546
- Acronym
- DCC
- Status last verified
- Aug 2017
- First submitted
- 15 Dec 2014
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02337088
- Acronym / sponsor ID
- DCC / 14-0546
- Keywords
- delayed cord clamping
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical reasons
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 16 Apr 2015 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 13 Jan 2015 (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 purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
Detailed description
Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood.
Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping.
Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 seconds | Active comparator | Procedure: Delayed cord clamping at 30 secondsFor subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery. |
| 60 seconds | Experimental | Procedure: Delayed cord clamping at 60 secondsFor subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women who are expected to deliver a very low birth weight infant
- Neonates born weighing >= 500g and <1500 grams
- Mother 18 years of age or older
- English speaking mother
Key exclusion criteria (8 listed)
- Placental abruption
- Vasa previa
- Fetal hydrops or other signs of fetal volume overload
- Other major fetal anomalies
- Placenta Accreta
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 clamping at 30 secondsFor subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery | Procedure or surgery | 30 seconds |
| Delayed cord clamping at 60 secondsFor subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery | Procedure or surgery | 60 seconds |
Primary outcome
Intraventricular hemorrhage
Time frame: During NICU admission up to 6 months
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
4 secondary outcomes
Hemoglobin and hematocrit
Time frame: During NICU admission up to 6 months
Need for blood transfusion
Time frame: During NICU admission up to 6 months
Bilirubin levels
Time frame: During NICU admission up to 6 months
Delivery room temperature
Time frame: Delivery
Results and safety
The study was stopped early (reason given: Logistical reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 at 30 seconds and Delayed cord clamping at 60 seconds in people with Very Low Birth Weight Infants and Premature Infants, run by University of Chicago 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 4 inclusion and 8 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 29 Aug 2017. 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: Logistical reasons). 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?
Intraventricular hemorrhage (time frame: During NICU admission up to 6 months). 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 29 Aug 2017.