Intraventricular HemorrhagePhase 2NCT00818220
Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
A Phase 2 study testing delayed umbilical cord clamping and Immediate cord clamping in people with Intraventricular Hemorrhage and Sepsis, run by University of Rhode Island at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraventricular Hemorrhage, Sepsis
- What is being tested?
- delayed umbilical cord clamping and Immediate cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2014
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
- Vaginal or cesarean birth
Who cannot join
- Congenital anomaly
- Multiple gestation
- Intent to withhold or withdraw care
- Severe or multiple maternal illnesses
- Mothers who are institutionalized or psychotic
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Protective Effects of Delayed Cord Clamping in VLBW Infants
The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.
Read the detailed description
The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines, circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.
- Conditions
- Intraventricular Hemorrhage, Sepsis
- Being tested
- delayed umbilical cord clamping, Immediate cord clamping
- Keywords
- intraventricular hemorrhage, sepsis, motor function, motor functioning at 7 months corrected age, cytokines in cord blood and at 6 and 20 hours of age, stem cells in cord blood and at 20 hours of age
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed umbilical cord clampingProcedure or surgery
Also called immediate cord clamping, cord milking
at birth, the clamping of the umbilical cord will be delayed 30 to 45 seconds while the child is held lower than the placenta. At the end of the time, the cord is milked once and the cord is clamped. If the obstetrician feels he cannot delay the cord clamping, then the cord can be milked 2 to 3 times.
Immediate cord clampingOther
Also called routine care
The umbilical cord is cut within 10 seconds after birth
| Study group | Role | What they receive |
|---|---|---|
| 1-Delayed Cord Clamping (DCC) | Experimental | Immediately after birth, the infant is placed in a warm blanket and held lower than the placenta. The research nurse counts out 30 to 45 seconds for the obstetrician. The cord is milked once and then clamped at 30 to 45 seconds after birth. Receives: Procedure: delayed umbilical cord clamping |
| 2-Immediate Cord Clamping (ICC) | Active comparator | Routine care which is immediate cord clamping Receives: Other: Immediate cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group
Measured: December, 2012
Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group
Measured: December 2012
Secondary outcomes (1)
VLBW infants in the DCC group will have better motor function at 7 months corrected age
Measured: November 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startFeb 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island, Brown University, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Judith S Mercer, University of Rhode Island
- Investigators
- Judith S Mercer, PhD, CNM, Principal investigator, University of Rhode Island, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818220
- Sponsor's protocol ID
- 2980022
- Other IDs
- 5R01NR010015-02
- Status last verified
- May 2015
- First submitted
- 5 Jan 2009
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.
PubMed 16585320Wang M, Mercer JS, Padbury JF. Delayed Cord Clamping in Infants with Suspected Intrauterine Growth Restriction. J Pediatr. 2018 Oct;201:264-268. doi: 10.1016/j.jpeds.2018.05.028. Epub 2018 Jun 25.
PubMed 29954605Mercer JS, Erickson-Owens DA, Vohr BR, Tucker RJ, Parker AB, Oh W, Padbury JF. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jan;168:50-55.e1. doi: 10.1016/j.jpeds.2015.09.068. Epub 2015 Nov 4.
PubMed 26547399Sommers R, Stonestreet BS, Oh W, Laptook A, Yanowitz TD, Raker C, Mercer J. Hemodynamic effects of delayed cord clamping in premature infants. Pediatrics. 2012 Mar;129(3):e667-72. doi: 10.1542/peds.2011-2550. Epub 2012 Feb 13.
PubMed 22331336
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Delayed Cord Clamping in VLBW Infants
- ClinicalTrials.gov ID
- NCT00818220
- Acronym / sponsor ID
- 2980022
- Conditions
- Intraventricular Hemorrhage, Sepsis
- Keywords
- intraventricular hemorrhage, sepsis, motor function, motor functioning at 7 months corrected age, cytokines in cord blood and at 6 and 20 hours of age, stem cells in cord blood and at 20 hours of age
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island, Brown University, National Institute of Nursing Research (NINR)
- Study start
- Feb 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Jan 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 purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.
Detailed description
The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines, circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Delayed Cord Clamping (DCC) | Experimental | Procedure: delayed umbilical cord clampingImmediately after birth, the infant is placed in a warm blanket and held lower than the placenta. The research nurse counts out 30 to 45 seconds for the obstetrician. The cord is milked once and then clamped at 30 to 45 seconds after birth. |
| 2-Immediate Cord Clamping (ICC) | Active comparator | Other: Immediate cord clampingRoutine care which is immediate cord clamping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
- Vaginal or cesarean birth
Key exclusion criteria (5 listed)
- Congenital anomaly
- Multiple gestation
- Intent to withhold or withdraw care
- Severe or multiple maternal illnesses
- Mothers who are institutionalized or psychotic
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 umbilical cord clampingAlso: immediate cord clamping, cord milkingat birth, the clamping of the umbilical cord will be delayed 30 to 45 seconds while the child is held lower than the placenta. At the end of the time, the cord is milked once and the cord is clamped. If the obstetrician feels he cannot delay the cord clamping, then the cord can be milked 2 to 3 times. | Procedure or surgery | 1-Delayed Cord Clamping (DCC) |
| Immediate cord clampingAlso: routine careThe umbilical cord is cut within 10 seconds after birth | Other | 2-Immediate Cord Clamping (ICC) |
Primary outcome
Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group
Time frame: December, 2012
Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group
Time frame: December 2012
1 secondary outcome
VLBW infants in the DCC group will have better motor function at 7 months corrected age
Time frame: November 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 16585320Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.
- Derived from this study: PubMed 29954605Wang M, Mercer JS, Padbury JF. Delayed Cord Clamping in Infants with Suspected Intrauterine Growth Restriction. J Pediatr. 2018 Oct;201:264-268. doi: 10.1016/j.jpeds.2018.05.028. Epub 2018 Jun 25.
- Derived from this study: PubMed 26547399Mercer JS, Erickson-Owens DA, Vohr BR, Tucker RJ, Parker AB, Oh W, Padbury JF. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jan;168:50-55.e1. doi: 10.1016/j.jpeds.2015.09.068. Epub 2015 Nov 4.
- Derived from this study: PubMed 22331336Sommers R, Stonestreet BS, Oh W, Laptook A, Yanowitz TD, Raker C, Mercer J. Hemodynamic effects of delayed cord clamping in premature infants. Pediatrics. 2012 Mar;129(3):e667-72. doi: 10.1542/peds.2011-2550. Epub 2012 Feb 13.
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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.
Judith S Mercer, PhD, CNM principal investigator
University of Rhode Island, Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing delayed umbilical cord clamping and Immediate cord clamping in people with Intraventricular Hemorrhage and Sepsis, run by University of Rhode Island 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 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: finished, as of the sponsor's last update on 27 May 2015. 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.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group (time frame: December, 2012). The study lists 2 primary outcomes in all. 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 NCT00818220, which also lists 4 linked publications.
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 27 May 2015.