Hypoxia, BrainPREMOD2NCT03145142
PREMOD2 With Near Infrared Spectroscopy Sub-study
A study testing Umbilical cord milking and Delayed Cord Clamping in people with Hypoxia, Brain and Premature Birth, run by Sharp HealthCare at 4 sites in 4 countries.
Trial summary
Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological… Read more about this study
- Who is it for?
- Ages 23 to 28 weeks
- Conditions the study is for
- Hypoxia, Brain, Premature Birth
- 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
- 121 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 6 Jun 2017to 15 Dec 2024
- 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 23 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 23 weeks 0 days to 27 weeks 6 days.
- Enrolled in PREMOD2 trial.
Who cannot join
- NIRS Device not available
- Research Personnel not available
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Official title: PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in cerebral oxygenation.
Read the detailed description
This substudy will include 400 infants <28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.
- Conditions
- Hypoxia, Brain, Premature Birth
- Being tested
- Umbilical cord milking, Delayed Cord Clamping
- Keywords
- Near-Infrared Spectroscopy
- Medical subject headings
- Hypoxia, Brain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. The procedure infuses a placental transfusion of blood into the preterm infant and can be done in 15-20 seconds
Delayed Cord ClampingProcedure or surgery
At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds. Receives: Procedure: Umbilical cord milking |
| Delayed Cord Clamping | Active comparator | Delayed clamping of the umbilical cord for at least 60 seconds. Receives: Procedure: Delayed Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
StO2 - 10M
Cerebral Tissue Oxygen Saturation in the Delivery Room
Measured: 1st 10 minutes of life
Secondary outcomes (4)
StO2 - 24H
Cerebral Tissue Oxygen Saturation in the NICU
Measured: 1st 24 hours of life
HR - 10M
Heart Rate in the Delivery Room
Measured: 1st 10 minutes of life
HR 24H
Heart rate in the NICU
Measured: 1st 24 hours of life
Blood Pressure NICU
Mean Blood Pressure in the 1st 24 hours
Measured: 2st 24 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start6 Jun 2017
- Primary completion17 Sep 2018
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxia, BrainStudies 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
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, University College Cork, University of Alberta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Anup C Katheria, MD, Principal investigator, Sharp Mary Birch Hospital for Women & Newborns
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145142
- Sponsor's protocol ID
- PREMOD2 - NIRS Sub-study
- Other IDs
- 1R01HD088646-01A1
- Acronym
- PREMOD2
- Status last verified
- Dec 2021
- First submitted
- 4 May 2017
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Katheria AC, Szychowski JM, Essers J, Mendler MR, Dempsey EM, Schmolzer GM, Arnell K, Rich WD, Hassen K, Allman P, Varner M, Cutter GR, Finer N. Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm. J Pediatr. 2020 Aug;223:51-56.e1. doi: 10.1016/j.jpeds.2020.04.010. Epub 2020 May 29.
PubMed 32482392
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
- ClinicalTrials.gov ID
- NCT03145142
- Acronym / sponsor ID
- PREMOD2 / PREMOD2 - NIRS Sub-study
- Conditions
- Hypoxia, Brain, Premature Birth
- Keywords
- Near-Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- University of Ulm, University College Cork, University of Alberta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 9 May 2017 (actual)
- 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.
Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in cerebral oxygenation.
Detailed description
This substudy will include 400 infants <28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Procedure: Umbilical cord milkingMilking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds. |
| Delayed Cord Clamping | Active comparator | Procedure: Delayed Cord ClampingDelayed clamping of the umbilical cord for at least 60 seconds. |
Who may qualify
- Ages
- 23 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 23 weeks 0 days to 27 weeks 6 days.
- Enrolled in PREMOD2 trial.
Key exclusion criteria (2 listed)
- NIRS Device not available
- Research Personnel not available
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 milkingAt delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. The procedure infuses a placental transfusion of blood into the preterm infant and can be done in 15-20 seconds | Procedure or surgery | Umbilical Cord Milking |
| Delayed Cord ClampingAt delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds. | Procedure or surgery | Delayed Cord Clamping |
Primary outcome
StO2 - 10M
Time frame: 1st 10 minutes of life
Cerebral Tissue Oxygen Saturation in the Delivery Room
4 secondary outcomes
StO2 - 24H
Time frame: 1st 24 hours of life
HR - 10M
Time frame: 1st 10 minutes of life
HR 24H
Time frame: 1st 24 hours of life
Blood Pressure NICU
Time frame: 2st 24 hours of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 32482392Katheria AC, Szychowski JM, Essers J, Mendler MR, Dempsey EM, Schmolzer GM, Arnell K, Rich WD, Hassen K, Allman P, Varner M, Cutter GR, Finer N. Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm. J Pediatr. 2020 Aug;223:51-56.e1. doi: 10.1016/j.jpeds.2020.04.010. Epub 2020 May 29.
- PREMOD2 main trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Mary Birch Hospital for Women & Newborns
4 sites in 4 countries: 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 Hypoxia, Brain and Premature Birth, run by Sharp HealthCare at 4 sites in 4 countries.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2021. 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, Canada, Germany, Ireland. 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?
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?
StO2 - 10M (time frame: 1st 10 minutes 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 NCT03145142, which also lists 1 linked publication.
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 13 Dec 2021.