Intraventricular HemorrhagePREMODNCT01866982
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
A study testing Umbilical Cord Milking and Delayed Cord Clamping in people with Intraventricular Hemorrhage, run by Sharp HealthCare at 3 sites in United States.
Trial summary
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- Umbilical Cord Milking and Delayed Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jul 2013to 10 Jan 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation
Who cannot join
- Planned vaginal breech delivery
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
- Fetal death in utero
- Red cell isoimmunization
- Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
- Placenta accreta or abruption
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Loma Linda Medical Center
Loma Linda, California, 92350
Sharp Mary Birch
San Diego, California, 92123
University of California, San Diego
San Diego, California, 92130
About this study
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- Umbilical Cord Milking, Delayed Cord Clamping
- Keywords
- umbilical cord milking, delayed cord clamping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingProcedure or surgery
Umbilical cord milked toward the neonate four times at a speed of 20cm/2seconds, prior to clamping and cutting umbilical cord. Procedure takes about 10-20 seconds.
Delayed Cord ClampingProcedure or surgery
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds Receives: Procedure: Umbilical Cord Milking |
| Delayed Cord Clamping | Active comparator | Delayed clamping of the umbilical cord for 45-60 seconds Receives: Procedure: Delayed Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior Vena Cava Flow
Measured: <12 hours of life
Secondary outcomes (21)
Delivery Room Interventions
Measured: 10 minutes of life
Hemoglobin
Measured: <1 hour
Hemoglobin
Measured: 12 hours
Hemoglobin
Measured: 4 weeks of life
Neurodevelopmental impairment 18-36 months
Measured: 18-36 months
Severe intraventricular hemorrhage (grade 3 or 4)
Measured: up to 24 weeks after birth
Phototherapy
Requirement and length of phototherapy
Measured: up to 24 weeks after birth
Ionotropic support
Requirement and length of ionotropic support
Measured: up to 24 weeks after birth
Neonatal intensive care unit (NICU) length of stay
Measured: up to 24 weeks after birth
Necrotizing enterocolitis
Measured: up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit
Measured: up to 24 weeks after birth
Ventilator time
Measured: up to 24 weeks after birth
Apgar score <7 at 5 minutes
Measured: at 5 minutes after birth
Umbilical cord pH < 7.0
Measured: up to 30 minutes after birth
Blood pressure in first 2 hours of admission to neonatal intensive care unit
Measured: 2 hours after birth
Polycythemia
Measured: up to 24 hours of life
Neonatal death
Measured: up to 24 weeks of life
Use of uterotonic agents
Measured: up to 1 hour after birth
Peak transcutaneous and/or serum bilirubin concentrations
Measured: up to 24 weeks after birt
Maternal hemoglobin
Measured: within 48 hours after delivery
Intraventricular Hemorrhage detected on Head Ultrasound
Measured: up to 24 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study start2 Jul 2013
- Primary completion1 Dec 2014
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup C Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866982
- Sponsor's protocol ID
- PREMOD
- Other IDs
- R03HD072934-01
- Acronym
- PREMOD
- Status last verified
- May 2018
- First submitted
- 29 May 2013
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368.
PubMed 26122803Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
PubMed 29246467
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
- ClinicalTrials.gov ID
- NCT01866982
- Acronym / sponsor ID
- PREMOD / PREMOD
- Conditions
- Intraventricular Hemorrhage
- Keywords
- umbilical cord milking, delayed cord clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 3 Jun 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.
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Procedure: Umbilical Cord MilkingMilking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds |
| Delayed Cord Clamping | Active comparator | Procedure: Delayed Cord ClampingDelayed clamping of the umbilical cord for 45-60 seconds |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation
Key exclusion criteria (6 listed)
- Planned vaginal breech delivery
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
- Fetal death in utero
- Red cell isoimmunization
- Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
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 |
|---|---|---|
| Umbilical Cord MilkingUmbilical cord milked toward the neonate four times at a speed of 20cm/2seconds, prior to clamping and cutting umbilical cord. Procedure takes about 10-20 seconds. | Procedure or surgery | Umbilical Cord Milking |
| Delayed Cord ClampingPerformed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting. | Procedure or surgery | Delayed Cord Clamping |
Primary outcome
Superior Vena Cava Flow
Time frame: <12 hours of life
21 secondary outcomes
Delivery Room Interventions
Time frame: 10 minutes of life
Hemoglobin
Time frame: <1 hour
Hemoglobin
Time frame: 12 hours
Hemoglobin
Time frame: 4 weeks of life
Neurodevelopmental impairment 18-36 months
Time frame: 18-36 months
Severe intraventricular hemorrhage (grade 3 or 4)
Time frame: up to 24 weeks after birth
Phototherapy
Time frame: up to 24 weeks after birth
Ionotropic support
Time frame: up to 24 weeks after birth
Neonatal intensive care unit (NICU) length of stay
Time frame: up to 24 weeks after birth
Necrotizing enterocolitis
Time frame: up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit
Time frame: up to 24 weeks after birth
Ventilator time
Time frame: up to 24 weeks after birth
Apgar score <7 at 5 minutes
Time frame: at 5 minutes after birth
Umbilical cord pH < 7.0
Time frame: up to 30 minutes after birth
Blood pressure in first 2 hours of admission to neonatal intensive care unit
Time frame: 2 hours after birth
Polycythemia
Time frame: up to 24 hours of life
Neonatal death
Time frame: up to 24 weeks of life
Use of uterotonic agents
Time frame: up to 1 hour after birth
Peak transcutaneous and/or serum bilirubin concentrations
Time frame: up to 24 weeks after birt
Maternal hemoglobin
Time frame: within 48 hours after delivery
Intraventricular Hemorrhage detected on Head Ultrasound
Time frame: up to 24 weeks after 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 24 May 2018.
- Background: PubMed 26122803Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368.
- Background: PubMed 29246467Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
Related trials for Intraventricular Hemorrhage
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The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Enrolling by invitationObservational study
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
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Early Lumbar Drainage for Intraventricular Hemorrhage
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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.
Anup C Katheria, MD principal investigator
Sharp HealthCare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Milking and Delayed Cord Clamping in people with Intraventricular Hemorrhage, run by Sharp HealthCare at 3 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 1 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 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Superior Vena Cava Flow (time frame: <12 hours of life). 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 NCT01866982, which also lists 2 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 24 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.