Infant, NewbornPhase 1/2NCT01222364
Delayed Cord Clamping in VLBW Infants
A Phase 1/2 study testing Standard Cord Clamping and Delayed Cord Clamping in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 4 sites in United States.
Trial summary
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. Read more about this study
- Who is it for?
- Ages 0 minutes to 1 minuteHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- What is being tested?
- Standard Cord Clamping and Delayed Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2000to Dec 2000
- Phase
- Phase 1/2
- 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 0 minutes to 1 minute
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born at participating centers at 24-27 weeks gestation
- Singletons
- Obstetrician approval for enrollment
- Parental consent
Who cannot join
- Prenatally diagnosed major congenital anomalies
- Intent to withhold or withdraw care
- Significant bleeding due to placenta previa or abruption
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama
Birmingham, Alabama, 35249-7335
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: Delayed Cord Clamping in VLBW Infants Pilot Study
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
Read the detailed description
This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.
This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Being tested
- Standard Cord Clamping, Delayed Cord Clamping
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Cord ClampingProcedure or surgery
Immediate clamping (<5 seconds) of the umbilical cord after delivery.
Delayed Cord ClampingProcedure or surgery
Clamping of the umbilical cord at 30-45 seconds after birth.
| Study group | Role | What they receive |
|---|---|---|
| Standard Cord Clamping | Active comparator | Not described Receives: Procedure: Standard Cord Clamping |
| Delayed Cord Clamping | Experimental | Not described Receives: Procedure: Delayed Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants enrolled
Number of infants enrolled in the pilot within 6 months.
Measured: 6 months
Secondary outcomes (5)
Intention to treat
Identify obstetricians willing to participate in randomizing subjects.
Measured: 6 months
Hematocrit level
Measured: 4 hours of age
Arterial blood pressure
Measured: 12 hours of age
Use of volume expansion or pressor therapy
Measured: 24 hours of age
Blood transfusions
Measured: Until hospital discharge or 120 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJun 2000
- Primary completionDec 2000
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- William Oh, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandAvroy A. Fanaroff, MD, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalEdward F. Donovan, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiWaldemar A. Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222364
- Sponsor's protocol ID
- NICHD-NRN-0023
- Other IDs
- U10HD021364, U01HD021438, U10HD027853, U10HD027904, M01RR000080, M01RR008084
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2010
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cord Clamping in VLBW Infants Pilot Study
- ClinicalTrials.gov ID
- NCT01222364
- Acronym / sponsor ID
- NICHD-NRN-0023
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jun 2000
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 18 Oct 2010 (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.
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
Detailed description
This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.
This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cord Clamping | Active comparator | Procedure: Standard Cord Clamping |
| Delayed Cord Clamping | Experimental | Procedure: Delayed Cord Clamping |
Who may qualify
- Ages
- 0 minutes to 1 minute
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born at participating centers at 24-27 weeks gestation
- Singletons
- Obstetrician approval for enrollment
- Parental consent
Key exclusion criteria (3 listed)
- Prenatally diagnosed major congenital anomalies
- Intent to withhold or withdraw care
- Significant bleeding due to placenta previa or abruption
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 |
|---|---|---|
| Standard Cord ClampingImmediate clamping (<5 seconds) of the umbilical cord after delivery. | Procedure or surgery | Standard Cord Clamping |
| Delayed Cord ClampingClamping of the umbilical cord at 30-45 seconds after birth. | Procedure or surgery | Delayed Cord Clamping |
Primary outcome
Infants enrolled
Time frame: 6 months
Number of infants enrolled in the pilot within 6 months.
5 secondary outcomes
Intention to treat
Time frame: 6 months
Hematocrit level
Time frame: 4 hours of age
Arterial blood pressure
Time frame: 12 hours of age
Use of volume expansion or pressor therapy
Time frame: 24 hours of age
Blood transfusions
Time frame: Until hospital discharge or 120 days of life
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 17 Jun 2026.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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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.
William Oh, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
Avroy A. Fanaroff, MD principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Edward F. Donovan, MD principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Standard Cord Clamping and Delayed Cord Clamping in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 4 sites 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 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined 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.
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?
Infants enrolled (time frame: 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 17 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.