Developmental DelayPhase 218moNCT01426698
18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
A Phase 2 study testing delayed cord clamping in people with Developmental Delay, run by University of Rhode Island at 1 site in United States.
Trial summary
The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age. Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Developmental Delay
- 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
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 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 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pregnancy between 24 and 31.6 weeks
- singleton fetus
- threatened preterm birth.
Who cannot join
- Fetuses: congenital anomalies
- Mothers: severe or multiple maternal illnesses
- Drug users or institutionalized or psychotic women
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.
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 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). In the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay and had higher scores on muscular control and function at 7 months corrected age. In the investigators current Phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7 months corrected age (age based on due date and not the pre-term birth rate).
Our objective for this new grant from the Thrasher Foundation is to examine the differences in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at 18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. Differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. The diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.
- Conditions
- Developmental Delay
- Being tested
- delayed cord clamping
- Keywords
- delayed cord clamping, developmental delay
- Medical subject headings
- Learning Disabilities
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 DCC
at birth, the obstetrical provider delays the cord clamping for 45 seconds while lowering the infant. At 45 seconds the cord is milked once and then clamped and cut.
| Study group | Role | What they receive |
|---|---|---|
| Immediate cord clamping | Active comparator | Infants in this arm will have had immediate cord clamping at birth which is routine care at the hospital Receives: Procedure: delayed cord clamping |
| Delayed Cord Clamping | Experimental | Intervention: Following the delivery of the infant, the obstetrician holds the infant approximately 10-15 inches below the mother's introitus at vaginal delivery or 10 to 15 inches below the level of the placenta at Cesarean section. The research nurse records the time when the infant's buttocks are delivered from the vagina or the uterus and counts out the time elapsed in ten second intervals to the obstetrician while he/she is doing the suctioning and drying maneuvers. At 30 to 45 seconds, the obstetrician milks the umbilical cord once, clamps, and cuts it. If the baby appears jeopardized in any way, the obstetrician can alter the protocol for the safety of the infant. Receives: Procedure: delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function
Very low birth weight infants in the delayed cord-clamping group will have better motor function at 18-22 months corrected age when compared with VLBW infants in the ICC group.
Measured: 18-22 months
Secondary outcomes (1)
Mental Functioning
Very low birth weight infants in the delayed cord-clamping group will have better mental functions at 18-22 months corrected age when compared with VLBW infants in the ICC group.
Measured: 18 to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionDec 2014
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 Developmental DelayStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 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
- Responsible party
- Principal investigator, Judith S Mercer, University of Rhode Island
- Investigators
- Judith S Mercer, PhD, CNM, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426698
- Sponsor's protocol ID
- Mercer - 9625
- Acronym
- 18mo
- Status last verified
- Dec 2014
- First submitted
- 19 Aug 2011
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mercer 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 19847185Wang 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 26547399
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
- ClinicalTrials.gov ID
- NCT01426698
- Acronym / sponsor ID
- 18mo / Mercer - 9625
- Conditions
- Developmental Delay
- Keywords
- delayed cord clamping, developmental delay
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Aug 2011 (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 examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.
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 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). In the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay and had higher scores on muscular control and function at 7 months corrected age. In the investigators current Phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7 months corrected age (age based on due date and not the pre-term birth rate).
Our objective for this new grant from the Thrasher Foundation is to examine the differences in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at 18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. Differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. The diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate cord clamping | Active comparator | Procedure: delayed cord clampingInfants in this arm will have had immediate cord clamping at birth which is routine care at the hospital |
| Delayed Cord Clamping | Experimental | Procedure: delayed cord clampingIntervention: Following the delivery of the infant, the obstetrician holds the infant approximately 10-15 inches below the mother's introitus at vaginal delivery or 10 to 15 inches below the level of the placenta at Cesarean section. The research nurse records the time when the infant's buttocks are delivered from the vagina or the uterus and counts out the time elapsed in ten second intervals to the obstetrician while he/she is doing the suctioning and drying maneuvers. At 30 to 45 seconds, the obstetrician milks the umbilical cord once, clamps, and cuts it. If the baby appears jeopardized in any way, the obstetrician can alter the protocol for the safety of the infant. |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- pregnancy between 24 and 31.6 weeks
- singleton fetus
- threatened preterm birth.
Key exclusion criteria (3 listed)
- Fetuses: congenital anomalies
- Mothers: severe or multiple maternal illnesses
- Drug users or institutionalized or psychotic women
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: DCCat birth, the obstetrical provider delays the cord clamping for 45 seconds while lowering the infant. At 45 seconds the cord is milked once and then clamped and cut. | Procedure or surgery | Delayed Cord Clamping, Immediate cord clamping |
Primary outcome
Motor function
Time frame: 18-22 months
Very low birth weight infants in the delayed cord-clamping group will have better motor function at 18-22 months corrected age when compared with VLBW infants in the ICC group.
1 secondary outcome
Mental Functioning
Time frame: 18 to 22 months
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 5 Dec 2014.
- 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.
- 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.
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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
Women and Infants Hospital 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 2 study testing delayed cord clamping in people with Developmental Delay, 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 3 inclusion and 3 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 5 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.
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?
Motor function (time frame: 18-22 months). 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 NCT01426698, 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 5 Dec 2014.