Placental TransfusionTerm-NRICNCT02827409
Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.
A study testing Short Delay Cord Clamping and Extended Delay Cord Clamping in people with Placental Transfusion, run by Anup Katheria, M.D. at 1 site in United States.
Trial summary
To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping. Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Placental Transfusion
- What is being tested?
- Short Delay Cord Clamping and Extended Delay Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2016
- 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 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
- Inclusion Criteria: Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery.
- Exclusion Criteria: Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Official title: A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.
To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.
Read the detailed description
All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required.
The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures.
In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.
- Conditions
- Placental Transfusion
- Being tested
- Short Delay Cord Clamping, Extended Delay Cord Clamping
- Keywords
- Delayed cord clamping
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Delay Cord ClampingProcedure or surgery
Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation.
Extended Delay Cord ClampingProcedure or surgery
Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside.
| Study group | Role | What they receive |
|---|---|---|
| Short Delay Cord Clamping | Active comparator | Subject will have umbilical cord clamped and cut by 1 minute of life. Receives: Procedure: Short Delay Cord Clamping |
| Extended Delay Cord Clamping | Active comparator | Subject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating Receives: Procedure: Extended Delay Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oxygenation
The need for oxygen, positive pressure ventilation, intubation
Measured: 12 hours of life
Secondary outcomes (14)
Heart rate
Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all
Measured: First 5 minutes of life
Oxygen saturation
data will be averaged over each minute of life
Measured: over the first 5 minutes of life
delivery room resuscitation
did the infant require resuscitation such as stimulation to breathe, oxygen, positive pressure ventilation etc.
Measured: at birth
Blood pressure
Measured: 12 hours of life
Hemoglobin
if Hemoglobin oximeter available
Measured: First 5 minutes of life
Hemoglobin
if Hemoglobin oximeter available
Measured: 12 hours of life
Apgar Score
1, 5 and 10 minute Apgar
Measured: First 10 minutes of life
Arterial and Venous Umbilical Cord Blood Gases
Measured: At birth
Need for NICU admission
Measured: at birth
Need for hypothermia for hypoxic ischemic encepalopathy
will be assessed by primary physician using defined criteria for hypothermia
Measured: at birth
Hospitalization days
Measured: up to 24 weeks
Bilirubin level
by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames.
Measured: 12-48 hours
Neurodevelopmental impairment
by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development
Measured: 12 month followup
Post delivery survey
Survey of practitioners (LD nurse, OB, neonatal team) about procedure
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionDec 2016
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 Placental TransfusionStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anup Katheria, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827409
- Sponsor's protocol ID
- Term-NRIC
- Acronym
- Term-NRIC
- Status last verified
- Jun 2017
- First submitted
- 5 Jul 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: small pilot study of term infants
Publications
Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.
PubMed 28526223
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.
- ClinicalTrials.gov ID
- NCT02827409
- Acronym / sponsor ID
- Term-NRIC / Term-NRIC
- Conditions
- Placental Transfusion
- Keywords
- Delayed cord clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anup Katheria, M.D.University, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2016 (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.
To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.
Detailed description
All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required.
The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures.
In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Delay Cord Clamping | Active comparator | Procedure: Short Delay Cord ClampingSubject will have umbilical cord clamped and cut by 1 minute of life. |
| Extended Delay Cord Clamping | Active comparator | Procedure: Extended Delay Cord ClampingSubject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Short Delay Cord ClampingDelay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation. | Procedure or surgery | Short Delay Cord Clamping |
| Extended Delay Cord ClampingExtended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside. | Procedure or surgery | Extended Delay Cord Clamping |
Primary outcome
Cerebral tissue oxygenation
Time frame: 12 hours of life
The need for oxygen, positive pressure ventilation, intubation
14 secondary outcomes
Heart rate
Time frame: First 5 minutes of life
Oxygen saturation
Time frame: over the first 5 minutes of life
delivery room resuscitation
Time frame: at birth
Blood pressure
Time frame: 12 hours of life
Hemoglobin
Time frame: First 5 minutes of life
Hemoglobin
Time frame: 12 hours of life
Apgar Score
Time frame: First 10 minutes of life
Arterial and Venous Umbilical Cord Blood Gases
Time frame: At birth
Need for NICU admission
Time frame: at birth
Need for hypothermia for hypoxic ischemic encepalopathy
Time frame: at birth
Hospitalization days
Time frame: up to 24 weeks
Bilirubin level
Time frame: 12-48 hours
Neurodevelopmental impairment
Time frame: 12 month followup
Post delivery survey
Time frame: at 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 8 Jun 2017.
- Derived from this study: PubMed 28526223Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.
- Individual participant dataSharing planned: No. small pilot study of term infants
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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 Katheria, MD principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Delay Cord Clamping and Extended Delay Cord Clamping in people with Placental Transfusion, run by Anup Katheria, M.D. 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?
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 8 Jun 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 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?
Cerebral tissue oxygenation (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 NCT02827409, 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 8 Jun 2017.