Bronchopulmonary DysplasiaPhase 1NCT00840983
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
A Phase 1 study testing delayed cord clamping in people with Bronchopulmonary Dysplasia and Necrotizing Enterocolitis, run by University of Rhode Island at 1 site in United States.
Trial summary
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage
- What is being tested?
- delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Dec 2006
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
- Obstetrician's approval of enrollment into study
- Parental consent
- Any mode of birth will be included
Who cannot join
- Obstetrician's refusal to enroll infants
- Parental refusal for consent
- Prenatally-diagnosed major congenital anomalies [or multiple gestations]
- Intent to withhold or withdraw care
- Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
- Mothers who are institutionalized or psychotic
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
Read the detailed description
When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence.
The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis, Motor Skills Disorders
- Being tested
- delayed cord clamping
- Keywords
- delayed cord clamping, very low birthweight infant, bronchopulmonary dysplasia, intraventricular hemorrhage, motor function
- Medical subject headings
- Bronchopulmonary Dysplasia, Enterocolitis, Necrotizing, Neonatal Sepsis, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed cord clampingProcedure or surgery
Also called cord clamping time
cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta
| Study group | Role | What they receive |
|---|---|---|
| 1-Immediate Cord Clamping | No intervention | infants received the routine care of immediate clamping of the umbilical cord |
| 2-Delayed Cord Clamping | Experimental | after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta. Receives: Procedure: delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped
Measured: 36 wks postmenstrual age
VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group
Measured: Hospital discharge
VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group
Measured: 7 months corrected age
Secondary outcomes (2)
Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group
Measured: NICU stay
Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.
Measured: NICU Stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startAug 2003
- Primary completionNov 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Thrasher Research Fund
- Responsible party
- Principal investigator, Judith S Mercer, University of Rhode Island
- Investigators
- Judith S Mercer, PhD, CNM, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840983
- Sponsor's protocol ID
- Mercer-K23-03
- Other IDs
- R01NR010015-01A2
- Status last verified
- Nov 2015
- First submitted
- 10 Feb 2009
- Last updated
- 30 Nov 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 16585320Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22.
PubMed 19847185Mercer 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 26547399
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
- ClinicalTrials.gov ID
- NCT00840983
- Acronym / sponsor ID
- Mercer-K23-03
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis, Motor Skills Disorders
- Keywords
- delayed cord clamping, very low birthweight infant, bronchopulmonary dysplasia, intraventricular hemorrhage, motor function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Thrasher Research Fund
- Study start
- Aug 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 11 Feb 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 was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
Detailed description
When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence.
The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Immediate Cord Clamping | No intervention | –infants received the routine care of immediate clamping of the umbilical cord |
| 2-Delayed Cord Clamping | Experimental | Procedure: delayed cord clampingafter birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
- Obstetrician's approval of enrollment into study
- Parental consent
- Any mode of birth will be included
Key exclusion criteria (6 listed)
- Obstetrician's refusal to enroll infants
- Parental refusal for consent
- Prenatally-diagnosed major congenital anomalies [or multiple gestations]
- Intent to withhold or withdraw care
- Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
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 clampingAlso: cord clamping timecord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta | Procedure or surgery | 2-Delayed Cord Clamping |
Primary outcome
VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped
Time frame: 36 wks postmenstrual age
VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group
Time frame: Hospital discharge
VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group
Time frame: 7 months corrected age
2 secondary outcomes
Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group
Time frame: NICU stay
Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.
Time frame: NICU Stay
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 30 Nov 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.
- Background: PubMed 19847185Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22.
- Results publication: 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing delayed cord clamping in people with Bronchopulmonary Dysplasia and Necrotizing Enterocolitis, 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 4 inclusion and 6 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 30 Nov 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 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.
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?
VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped (time frame: 36 wks postmenstrual age). The study lists 3 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 NCT00840983, which also lists 3 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 30 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.