Infant, Extremely PrematureNCT01666847
Milking the Umbilical Cord for Extreme Preterm Infants
A study testing Milking the umbilical cord before cord clamping in people with Infant, Extremely Premature, run by St. Louis University at 2 sites in United States.
Trial summary
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant, Extremely Premature
- What is being tested?
- Milking the umbilical cord before cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jul 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound
- informed consent obtained by the pregnant women prior to delivery of the infant.
Who cannot join
- pregnancy with a multiple gestation
- infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
- infants with hydrops fetalis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
Saint Louis University, Division of Neonatology, SSM St. Mary's Health Center
St Louis, Missouri, 63117
About this study
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.
The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.
Read the detailed description
Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.
- Conditions
- Infant, Extremely Premature
- Being tested
- Milking the umbilical cord before cord clamping
- Keywords
- Umbilical Cord Milking, Extremely Low Birth Weight Infant (ELBW)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milking the umbilical cord before cord clampingProcedure or surgery
The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.
| Study group | Role | What they receive |
|---|---|---|
| Cord Milking | Experimental | Infant receiving cord milking intervention before umbilical cord clamped. Receives: Procedure: Milking the umbilical cord before cord clamping |
| Immediate Cord Clamping | No intervention | Infant whose umbilical cord is immediately clamped after delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping
Measured: Within 4 hour of birth
To evaluate and compare the incidence and numbers of blood transfusions after cord milking
Measured: Prior to initial infant discharge
Secondary outcomes (5)
To evaluate and compare blood pressure after intervention and need for support medications
Measured: For first seven days of life
To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy
Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.
Measured: Three weeks
To evaluate the incidence of complications of prematurity in the study and control groups
Measured: Until 3 years corrected gestational age
To evaluate long term outcomes of prematurity in both groups in a follow-up study
Measured: Until 3 years corrected gestational age
To compare the difference in hemoglobin and hematocrit from umbilical cord blood
Measured: Within 4 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infant, Extremely PrematureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Josephsen M.D., St. Louis University
- Investigators
- Justin B Josephsen, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666847
- Sponsor's protocol ID
- 21429
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2012
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hosono S, Mugishima H, Fujita H, Hosono A, Minato M, Okada T, Takahashi S, Harada K. Umbilical cord milking reduces the need for red cell transfusions and improves neonatal adaptation in infants born at less than 29 weeks' gestation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F14-9. doi: 10.1136/adc.2006.108902. Epub 2007 Jan 18.
PubMed 17234653Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11. doi: 10.1097/01.AOG.0000277262.80793.0d.
PubMed 17766607Rabe H, Jewison A, Fernandez Alvarez R, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-211. doi: 10.1097/AOG.0b013e3181fe46ff.
PubMed 21252731Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2.
PubMed 15495045Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.
PubMed 17890882
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milking the Umbilical Cord for Extreme Preterm Infants
- ClinicalTrials.gov ID
- NCT01666847
- Acronym / sponsor ID
- 21429
- Conditions
- Infant, Extremely Premature
- Keywords
- Umbilical Cord Milking, Extremely Low Birth Weight Infant (ELBW)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Aug 2012 (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.
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.
The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.
Detailed description
Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cord Milking | Experimental | Procedure: Milking the umbilical cord before cord clampingInfant receiving cord milking intervention before umbilical cord clamped. |
| Immediate Cord Clamping | No intervention | –Infant whose umbilical cord is immediately clamped after delivery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound
- informed consent obtained by the pregnant women prior to delivery of the infant.
Key exclusion criteria (3 listed)
- pregnancy with a multiple gestation
- infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
- infants with hydrops fetalis
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 the umbilical cord before cord clampingThe procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant. | Procedure or surgery | Cord Milking |
Primary outcome
To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping
Time frame: Within 4 hour of birth
To evaluate and compare the incidence and numbers of blood transfusions after cord milking
Time frame: Prior to initial infant discharge
5 secondary outcomes
To evaluate and compare blood pressure after intervention and need for support medications
Time frame: For first seven days of life
To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy
Time frame: Three weeks
To evaluate the incidence of complications of prematurity in the study and control groups
Time frame: Until 3 years corrected gestational age
To evaluate long term outcomes of prematurity in both groups in a follow-up study
Time frame: Until 3 years corrected gestational age
To compare the difference in hemoglobin and hematocrit from umbilical cord blood
Time frame: Within 4 hours of birth
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 14 Aug 2019.
- Background: PubMed 17234653Hosono S, Mugishima H, Fujita H, Hosono A, Minato M, Okada T, Takahashi S, Harada K. Umbilical cord milking reduces the need for red cell transfusions and improves neonatal adaptation in infants born at less than 29 weeks' gestation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F14-9. doi: 10.1136/adc.2006.108902. Epub 2007 Jan 18.
- Background: PubMed 17766607Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11. doi: 10.1097/01.AOG.0000277262.80793.0d.
- Background: PubMed 21252731Rabe H, Jewison A, Fernandez Alvarez R, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-211. doi: 10.1097/AOG.0b013e3181fe46ff.
- Background: PubMed 15495045Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2.
- Background: PubMed 17890882Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.
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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.
Justin B Josephsen, MD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milking the umbilical cord before cord clamping in people with Infant, Extremely Premature, run by St. Louis University at 2 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 2 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping (time frame: Within 4 hour of birth). 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 NCT01666847, which also lists 5 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 14 Aug 2019.