EncephalopathyNCT02445417
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
An observational study of Encephalopathy and Asphyxia Newborns, run by Sharp HealthCare at 1 site in United States.
Trial summary
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room. Read more about this study
- Who is it for?
- Ages 36 to 44 weeksHealthy volunteers can take part
- Conditions the study is for
- Encephalopathy, Asphyxia Newborns
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2015to 31 Aug 2017
- Phase
- Observational
- 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 36 to 44 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term infants at delivery (37-44 weeks gestational age)
Who may be able to join
- Signed Informed consent
Who cannot join
- 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
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.
Read the detailed description
There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes.
This study is designed to record EEG during birth transition through the first 10 minutes of life.
- Conditions
- Encephalopathy, Asphyxia Newborns
- Keywords
- Perinatal depression
- Medical subject headings
- Brain Diseases, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EES | Epidermal Electronic System | |
| Hydrogel Electrode | Hydrogel based EEG electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG recorded
May be up to 60 minutes if applicable
Measured: Birth to 10 minutes of life
Secondary outcomes (2)
Skin irritation from EES or hydrogel electrodes
Redness, excoriation
Measured: 60 minutes of life
Successful adhesion of EES to skin
Redness, excoriation
Measured: 60 minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study start25 Jun 2015
- Primary completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EncephalopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- The Hartwell Foundation
- Responsible party
- Principal investigator, M J Harbert, Sharp HealthCare
- Investigators
- Mary J Harbert, MD, Principal investigator, Sharp Mary Birch Hospital for Women & Newborns
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445417
- Sponsor's protocol ID
- Transition
- Status last verified
- Sep 2018
- First submitted
- 31 Mar 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8.
PubMed 21524031Perez A, Ritter S, Brotschi B, Werner H, Caflisch J, Martin E, Latal B. Long-term neurodevelopmental outcome with hypoxic-ischemic encephalopathy. J Pediatr. 2013 Aug;163(2):454-9. doi: 10.1016/j.jpeds.2013.02.003. Epub 2013 Mar 14.
PubMed 23498155Massaro AN, Tsuchida T, Kadom N, El-Dib M, Glass P, Baumgart S, Chang T. aEEG evolution during therapeutic hypothermia and prediction of NICU outcome in encephalopathic neonates. Neonatology. 2012;102(3):197-202. doi: 10.1159/000339570. Epub 2012 Jul 12.
PubMed 22796967Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
PubMed 23440789Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
PubMed 12563063Kim DH, Lu N, Ma R, Kim YS, Kim RH, Wang S, Wu J, Won SM, Tao H, Islam A, Yu KJ, Kim TI, Chowdhury R, Ying M, Xu L, Li M, Chung HJ, Keum H, McCormick M, Liu P, Zhang YW, Omenetto FG, Huang Y, Coleman T, Rogers JA. Epidermal electronics. Science. 2011 Aug 12;333(6044):838-43. doi: 10.1126/science.1206157.
PubMed 21836009Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8.
PubMed 23313424
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
- ClinicalTrials.gov ID
- NCT02445417
- Acronym / sponsor ID
- Transition
- Conditions
- Encephalopathy, Asphyxia Newborns
- Keywords
- Perinatal depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- The Hartwell Foundation
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- First posted
- 15 May 2015 (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 early identification of asphyxiated newborns through eeg starting in the delivery room.
Detailed description
There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes.
This study is designed to record EEG during birth transition through the first 10 minutes of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EES | – | –Epidermal Electronic System |
| Hydrogel Electrode | – | –Hydrogel based EEG electrode |
Who may qualify
- Ages
- 36 to 44 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term infants at delivery (37-44 weeks gestational age)
Key inclusion criteria (1 listed)
- Signed Informed consent
Key exclusion criteria (1 listed)
- Known congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG recorded
Time frame: Birth to 10 minutes of life
May be up to 60 minutes if applicable
2 secondary outcomes
Skin irritation from EES or hydrogel electrodes
Time frame: 60 minutes of life
Successful adhesion of EES to skin
Time frame: 60 minutes 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 7 Sep 2018.
- Background: PubMed 21524031Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8.
- Background: PubMed 23498155Perez A, Ritter S, Brotschi B, Werner H, Caflisch J, Martin E, Latal B. Long-term neurodevelopmental outcome with hypoxic-ischemic encephalopathy. J Pediatr. 2013 Aug;163(2):454-9. doi: 10.1016/j.jpeds.2013.02.003. Epub 2013 Mar 14.
- Background: PubMed 22796967Massaro AN, Tsuchida T, Kadom N, El-Dib M, Glass P, Baumgart S, Chang T. aEEG evolution during therapeutic hypothermia and prediction of NICU outcome in encephalopathic neonates. Neonatology. 2012;102(3):197-202. doi: 10.1159/000339570. Epub 2012 Jul 12.
- Background: PubMed 23440789Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
- Background: PubMed 12563063Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
- Background: PubMed 21836009Kim DH, Lu N, Ma R, Kim YS, Kim RH, Wang S, Wu J, Won SM, Tao H, Islam A, Yu KJ, Kim TI, Chowdhury R, Ying M, Xu L, Li M, Chung HJ, Keum H, McCormick M, Liu P, Zhang YW, Omenetto FG, Huang Y, Coleman T, Rogers JA. Epidermal electronics. Science. 2011 Aug 12;333(6044):838-43. doi: 10.1126/science.1206157.
- Background: PubMed 23313424Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8.
- cdc: Complications during pregnancy \& birth are among leading causes of infant mortalityLink provided by the sponsor.
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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.
Mary J Harbert, MD principal investigator
Sharp Mary Birch Hospital for Women & Newborns
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy and Asphyxia Newborns, 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 1 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 7 Sep 2018. 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?
EEG recorded (time frame: Birth to 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 NCT02445417, which also lists 7 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 7 Sep 2018.