Intraventricular HemorrhageNRICNCT02231411
Neonatal Resuscitation With Intact Cord
A study testing V-DCC, Delayed cord clamping and Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels in people with Intraventricular Hemorrhage, run by Sharp HealthCare at 1 site in United States.
Trial summary
The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth. Read more about this study
- Who is it for?
- Ages 23 to 31 weeks
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- V-DCC, Delayed cord clamping and Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 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 23 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)
Who cannot join
- Gestational Age: Parents decline consent (Reason: Can only perform intervention at time of delivery)
- Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological function)
- Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of delivery)
- Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin during delayed cord clamping)
- Placenta Accreta
- Prolonged premature rupture of membranes (> 2 weeks) prior to 23 weeks gestation
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
The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.
Read the detailed description
Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will receive routine care PLUS administration of CPAP and if need positive pressure ventilation. The outcome is to determine whether the addition of ventilation provides a larger placental transfusion and a smoother transition at birth.
- Conditions
- Intraventricular Hemorrhage
- Being tested
- V-DCC, Delayed cord clamping, Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
- Keywords
- Delayed Cord Clamping, Pulmonary Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-DCCProcedure or surgery
Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
Delayed cord clampingProcedure or surgery
Delayed clamping of the umbilical cord for 60 seconds
Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towelsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ventilation during DCC (V-DCC) | Active comparator | Measuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL) Receives: Procedure: V-DCC |
| DCC plus dry and stimulate | Active comparator | Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL) Receives: Procedure: Delayed cord clamping; Procedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Hematocrit
Measured: within 24 hours
Secondary outcomes (40)
Maximum inspired oxygen (FiO2) (percentage)
Measured: over the first 5 minutes of life
Positive Pressure Ventilation given
Measured: 1 minute
DR interventions after delayed cord clamping complete
PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)
Measured: 10 minutes of life
Maximum Peak Inspiratory Pressure (cm H2O)
Measured: over the first 5 minutes of life
Time to reach heart rate >100 beats per minute (seconds)
Measured: over the first 5 minutes of life
Time oxygen saturation within and outside of target range (seconds)
Measured: over the first 5 minutes of life
Time of the resuscitation (minutes)
Measured: up to 30 minutes of life
Time to demonstrate cycling of end tidal CO2 (seconds)
Evaluated by analysis of video recording
Measured: First minute of life
Maximum End Tidal CO2 (mm Hg)
Measured: up to 30 minutes of life
Intubation (yes/no) in DR/NICU and age (hours)
Measured: up to 7 days of life
Surfactant (yes/no) in DR/NICU and age (hours)
Measured: up to 7 days of life
SVC Flow (ml/kg/min)
plus/minus 6 hours
Measured: target time 6 hours of life
Right ventricular output (ml/kg/min)
plus/minus 6 hours
Measured: 6 hours of life
Cardiac Output by Electrical Cardiometry (ml/kg/min)
Measured: over the first 24 hours of life
Cerebral StO2 by Near-Infrared Spectroscopy
Measured: over the first 24 hours of life
Fractional Oxygen Extraction by Near-Infrared Spectroscopy
Measured: 24 hours of life
Color Doppler diameter of ductus arteriosus shunt (mm)
plus/minus 6 hours
Measured: 6 hours of life
Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
plus/minus 6 hours
Measured: 6 hours of life
Color Doppler diameter of inter-atrial shunt (mm)
plus/minus 6 hours
Measured: 6 hours of life
Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
plus/minus 6 hours
Measured: 6 hours of life
Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
plus/minus 6 hours
Measured: 6 hours of life
Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
Measured: over the first 6 hours of life
Arterial and venous cord pH
Measured: at birth (first minute of life)
Peak total serum bilirubin (mg/dL)
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Duration of phototherapy days
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Serum hematocrit
Measured: at birth, 12 hours, and 30 days of life
Admission temperatures (degree Centigrade)
Measured: within 1 hour of life
Urine output (ml/kg/day)
Measured: over the first 72 hours
Mean Arterial Blood pressure (mm Hg)
Measured: over the first 24 hours
Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
Measured: over the first 72 hours
Use of postnatal steroids (yes/no)
Measured: 4 months or until hospital discharge
Presence of intraventricular hemorrhage (yes/no)
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
Measured: 4 months or until hospital discharge
Presence of PVL (yes/no)
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Mortality (yes/no)
Measured: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Placental Weight
Measured: weighed within 24 hours of delivery of the infant
Maternal Hemoglobin
Measured: in the first 48 hours post delivery of the infant
Mean Airway Pressure (MAP)
Measured: First 5 minutes of life
Duration of CPAP or PPV
Evaluated by analysis of video recording
Measured: First one minute of life
Length of umbilical cord allows use of LifeStart bed
Evaluated by analysis of video recording
Measured: First one minute of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 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 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
- Care provider
- Enrolment
- 150 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
- NCT02231411
- Sponsor's protocol ID
- NRIC
- Other IDs
- 5R21HD080594
- Acronym
- NRIC
- Status last verified
- May 2017
- First submitted
- 11 Aug 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26.
PubMed 27574999
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Resuscitation With Intact Cord
- ClinicalTrials.gov ID
- NCT02231411
- Acronym / sponsor ID
- NRIC / NRIC
- Conditions
- Intraventricular Hemorrhage
- Keywords
- Delayed Cord Clamping, Pulmonary Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Sep 2014 (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.
The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.
Detailed description
Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will receive routine care PLUS administration of CPAP and if need positive pressure ventilation. The outcome is to determine whether the addition of ventilation provides a larger placental transfusion and a smoother transition at birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilation during DCC (V-DCC) | Active comparator | Procedure: V-DCCMeasuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL) |
| DCC plus dry and stimulate | Active comparator | Procedure: Delayed cord clamping, Procedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towelsMeasuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL) |
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)
Key exclusion criteria (6 listed)
- Gestational Age: Parents decline consent (Reason: Can only perform intervention at time of delivery)
- Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological function)
- Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of delivery)
- Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin during delayed cord clamping)
- Placenta Accreta
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 |
|---|---|---|
| V-DCCVentilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds | Procedure or surgery | Ventilation during DCC (V-DCC) |
| Delayed cord clampingDelayed clamping of the umbilical cord for 60 seconds | Procedure or surgery | DCC plus dry and stimulate |
| Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels | Procedure or surgery | DCC plus dry and stimulate |
Primary outcome
Peak Hematocrit
Time frame: within 24 hours
40 secondary outcomes
Maximum inspired oxygen (FiO2) (percentage)
Time frame: over the first 5 minutes of life
Positive Pressure Ventilation given
Time frame: 1 minute
DR interventions after delayed cord clamping complete
Time frame: 10 minutes of life
Maximum Peak Inspiratory Pressure (cm H2O)
Time frame: over the first 5 minutes of life
Time to reach heart rate >100 beats per minute (seconds)
Time frame: over the first 5 minutes of life
Time oxygen saturation within and outside of target range (seconds)
Time frame: over the first 5 minutes of life
Time of the resuscitation (minutes)
Time frame: up to 30 minutes of life
Time to demonstrate cycling of end tidal CO2 (seconds)
Time frame: First minute of life
Maximum End Tidal CO2 (mm Hg)
Time frame: up to 30 minutes of life
Intubation (yes/no) in DR/NICU and age (hours)
Time frame: up to 7 days of life
Surfactant (yes/no) in DR/NICU and age (hours)
Time frame: up to 7 days of life
SVC Flow (ml/kg/min)
Time frame: target time 6 hours of life
Right ventricular output (ml/kg/min)
Time frame: 6 hours of life
Cardiac Output by Electrical Cardiometry (ml/kg/min)
Time frame: over the first 24 hours of life
Cerebral StO2 by Near-Infrared Spectroscopy
Time frame: over the first 24 hours of life
Fractional Oxygen Extraction by Near-Infrared Spectroscopy
Time frame: 24 hours of life
Color Doppler diameter of ductus arteriosus shunt (mm)
Time frame: 6 hours of life
Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
Time frame: 6 hours of life
Color Doppler diameter of inter-atrial shunt (mm)
Time frame: 6 hours of life
Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
Time frame: 6 hours of life
Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
Time frame: 6 hours of life
Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
Time frame: over the first 6 hours of life
Arterial and venous cord pH
Time frame: at birth (first minute of life)
Peak total serum bilirubin (mg/dL)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Duration of phototherapy days
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Serum hematocrit
Time frame: at birth, 12 hours, and 30 days of life
Admission temperatures (degree Centigrade)
Time frame: within 1 hour of life
Urine output (ml/kg/day)
Time frame: over the first 72 hours
Mean Arterial Blood pressure (mm Hg)
Time frame: over the first 24 hours
Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
Time frame: over the first 72 hours
Use of postnatal steroids (yes/no)
Time frame: 4 months or until hospital discharge
Presence of intraventricular hemorrhage (yes/no)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
Time frame: 4 months or until hospital discharge
Presence of PVL (yes/no)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Mortality (yes/no)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Placental Weight
Time frame: weighed within 24 hours of delivery of the infant
Maternal Hemoglobin
Time frame: in the first 48 hours post delivery of the infant
Mean Airway Pressure (MAP)
Time frame: First 5 minutes of life
Duration of CPAP or PPV
Time frame: First one minute of life
Length of umbilical cord allows use of LifeStart bed
Time frame: First one minute of life
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 30 May 2017.
- Derived from this study: PubMed 27574999Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-DCC, Delayed cord clamping and Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels in people with Intraventricular Hemorrhage, run by Sharp HealthCare 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 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 30 May 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?
Peak Hematocrit (time frame: within 24 hours). 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 NCT02231411, 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 30 May 2017.