PrematurityNCT01819532
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
A study testing Milking group and Immediate cord clamping in people with Prematurity, run by Johns Hopkins University at 1 site in United States.
Trial summary
Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Prematurity
- What is being tested?
- Milking group and Immediate cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2013
- 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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Preterm neonates delivered between 24 0/7 and 32 6/7
- Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
- Written parental consent
Who cannot join
- Multiple gestation pregnancies (twins or higher order multiples)
- Rh or other antibody sensitization
- Hydrops fetalis
- Known major congenital abnormality
- Suspected abruptio placentae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial
Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.
- Conditions
- Prematurity
- Being tested
- Milking group, Immediate cord clamping
- Keywords
- neonate, umbilical cord, cord milking, 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.
Milking groupProcedure or surgery
The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.
Immediate cord clampingProcedure or surgery
The umbilical cord will be clamped and cut immediately after delivery of the neonate.
| Study group | Role | What they receive |
|---|---|---|
| Immediate umbilical cord clamping | Active comparator | The umbilical cord will be clamped immediately after delivery. Receives: Procedure: Immediate cord clamping |
| Cord milking group | Experimental | The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes. Receives: Procedure: Milking group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin during NICU course
Measured: within 24 hours of birth and through NICU stay
Secondary outcomes (14)
1-min Apgar
Measured: at 1 minute of life
5 min Apgar
Measured: at 5 minutes of life
Blood Sugar upon admission to NICU
Measured: within 1 hour of birth
Temperature on admission to NICU
Measured: within 1 hour of birth
Cord blood pH
Measured: within 1 hour of birth
Blood pressure upon admission to NICU
Measured: within 1 hour of birth
Number of volume challenges in first 24 hours of life
Measured: at 24 hours of birth
Days requiring ventilation
Measured: 2 months
Neonatal death
Measured: 6 months
Length of hospital stay
Measured: 6 months
Intraventricular hemorrhage
Measured: 6 months
Number and volume of blood transfusions
Measured: 10 units
duration of phototherapy
Measured: 1 month
Maximum serum bilirubin
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: extremely poor recruitment \& since the study was approved, medical practice has evolved to where cord milking is now common practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Bienstock, MD MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819532
- Sponsor's protocol ID
- NA_00046760
- Status last verified
- Dec 2017
- First submitted
- 6 Oct 2011
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01819532
- Acronym / sponsor ID
- NA_00046760
- Conditions
- Prematurity
- Keywords
- neonate, umbilical cord, cord milking, prematurity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: extremely poor recruitment \& since the study was approved, medical practice has evolved to where cord milking is now common practice.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Mar 2013 (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.
Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate umbilical cord clamping | Active comparator | Procedure: Immediate cord clampingThe umbilical cord will be clamped immediately after delivery. |
| Cord milking group | Experimental | Procedure: Milking groupThe umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Preterm neonates delivered between 24 0/7 and 32 6/7
- Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
- Written parental consent
Key exclusion criteria (5 listed)
- Multiple gestation pregnancies (twins or higher order multiples)
- Rh or other antibody sensitization
- Hydrops fetalis
- Known major congenital abnormality
- Suspected abruptio placentae
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 |
|---|---|---|
| Milking groupThe umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord. | Procedure or surgery | Cord milking group |
| Immediate cord clampingThe umbilical cord will be clamped and cut immediately after delivery of the neonate. | Procedure or surgery | Immediate umbilical cord clamping |
Primary outcome
Hemoglobin during NICU course
Time frame: within 24 hours of birth and through NICU stay
14 secondary outcomes
1-min Apgar
Time frame: at 1 minute of life
5 min Apgar
Time frame: at 5 minutes of life
Blood Sugar upon admission to NICU
Time frame: within 1 hour of birth
Temperature on admission to NICU
Time frame: within 1 hour of birth
Cord blood pH
Time frame: within 1 hour of birth
Blood pressure upon admission to NICU
Time frame: within 1 hour of birth
Number of volume challenges in first 24 hours of life
Time frame: at 24 hours of birth
Days requiring ventilation
Time frame: 2 months
Neonatal death
Time frame: 6 months
Length of hospital stay
Time frame: 6 months
Intraventricular hemorrhage
Time frame: 6 months
Number and volume of blood transfusions
Time frame: 10 units
duration of phototherapy
Time frame: 1 month
Maximum serum bilirubin
Time frame: 1 month
Results and safety
The study was stopped early (reason given: extremely poor recruitment \& since the study was approved, medical practice has evolved to where cord milking is now common practice.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.
Jessica Bienstock, MD MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milking group and Immediate cord clamping in people with Prematurity, run by Johns Hopkins University 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 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: stopped early, as of the sponsor's last update on 11 Dec 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: extremely poor recruitment \& since the study was approved, medical practice has evolved to where cord milking is now common practice.). 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?
Hemoglobin during NICU course (time frame: within 24 hours of birth and through NICU stay). 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 11 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.