Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at BirthNCT03149731
Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates
An observational study of Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at Birth, run by Xijing Hospital at 1 site in China.
Trial summary
Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify the percent saturation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at Birth
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2017to 1 Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 120 ASA class I or II parturients between 37 to 42 weeks of gestation with singleton vertex pregnancy and scheduled for elective cesarean delivery under spinal anesthesia.
Who may be able to join
- Term infants (37-42 weeks of gestation)
- Elective cesarean section after pregnancy
Who cannot join
- Thick hair that makes good measurements difficult/impossible
- Obvious malformations or syndrome
- Complications in relation to the cesarean section
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 029
Li Tian, +86 29 84775337, tianli_fmmu@163.com
About this study
Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify the percent saturation. There is also available evidence shows that tissue oximetry is sensitive and has a quicker response to physiological derangement, such as bradycardia, in preterm newborns. Additionally, it is demonstrated that reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. The SafeBoosC phase II randomized clinical trial hypothesizes that the burden of hypo- and hyperoxia can be reduced, and consequently the risk of brain injury, by the combined use of close monitoring of the cerebral rStO2 and an evidence-based treatment guideline to correct deviations in rStO2 outside a predefined target range. In this study, we will monitor 2 different tissue beds including cerebral and abdominal somatic tissue rStO2 and SpO2 in neonates. Further research is needed to investigate clinical implications for using this measure to drive therapeutic interventions.
- Being tested
- NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
The recent technological advancement of tissue NIRS enables continuous, real time and bedside monitoring of hemoglobin oxygen saturation in mixed arterial, venous, and primarily capillary blood in the tissue bed being probed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral and abdominal NIRS in neonates
Cerebral and abdominal tissue oxygen saturation was obtained using 4-wavelength (690, 780, 805 and 850nm) near-infrared spectroscopy (FORE-SIGHT, CAS Medical Systems, Branford, CT) with a transducer containing a fiber optic emitter and one detector located 25mm from the light source. A non-adhesive optode (FORE-SIGHT sensor kit small, CAS Medical Systems, Branford, CT) was placed on the left forehead and abdomen.
Measured: After birth in 20 min
Secondary outcomes (1)
Pulse oximetry in neonates
Pulse oximetry data (SpO2) were collected in a time-synchronized fashion with the NIRS data using the transport monitor (Philips IntelliVue MMS X2 equipped with multi-measurement module, Philips Healthcare, Andover, MA) and a non-adhesive probe placed on the hand or foot (Neonatal-Adult SpO2 Sensor, Philips Healthcare, Andover, MA).
Measured: After birth in 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start8 May 2017
- Primary completion1 Nov 2017 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at BirthStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian Li-1, Xijing Hospital
- Investigators
- Li Tian, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149731
- Sponsor's protocol ID
- XijingHosp
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.
PubMed 20472937BOOST II United Kingdom Collaborative Group; BOOST II Australia Collaborative Group; BOOST II New Zealand Collaborative Group; Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013 May 30;368(22):2094-104. doi: 10.1056/NEJMoa1302298. Epub 2013 May 5.
PubMed 23642047Spaeder MC, Klugman D, Skurow-Todd K, Glass P, Jonas RA, Donofrio MT. Perioperative Near-Infrared Spectroscopy Monitoring in Neonates With Congenital Heart Disease: Relationship of Cerebral Tissue Oxygenation Index Variability With Neurodevelopmental Outcome. Pediatr Crit Care Med. 2017 Mar;18(3):213-218. doi: 10.1097/PCC.0000000000001056.
PubMed 28067688Schmid MB, Hopfner RJ, Lenhof S, Hummler HD, Fuchs H. Cerebral oxygenation during intermittent hypoxemia and bradycardia in preterm infants. Neonatology. 2015;107(2):137-46. doi: 10.1159/000368294. Epub 2014 Dec 20.
PubMed 25531368
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates
- ClinicalTrials.gov ID
- NCT03149731
- Acronym / sponsor ID
- XijingHosp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 11 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.
Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify the percent saturation. There is also available evidence shows that tissue oximetry is sensitive and has a quicker response to physiological derangement, such as bradycardia, in preterm newborns. Additionally, it is demonstrated that reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. The SafeBoosC phase II randomized clinical trial hypothesizes that the burden of hypo- and hyperoxia can be reduced, and consequently the risk of brain injury, by the combined use of close monitoring of the cerebral rStO2 and an evidence-based treatment guideline to correct deviations in rStO2 outside a predefined target range. In this study, we will monitor 2 different tissue beds including cerebral and abdominal somatic tissue rStO2 and SpO2 in neonates. Further research is needed to investigate clinical implications for using this measure to drive therapeutic interventions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 120 ASA class I or II parturients between 37 to 42 weeks of gestation with singleton vertex pregnancy and scheduled for elective cesarean delivery under spinal anesthesia.
Key inclusion criteria (2 listed)
- Term infants (37-42 weeks of gestation)
- Elective cesarean section after pregnancy
Key exclusion criteria (3 listed)
- Thick hair that makes good measurements difficult/impossible
- Obvious malformations or syndrome
- Complications in relation to the cesarean section
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 |
|---|---|---|
| NIRSThe recent technological advancement of tissue NIRS enables continuous, real time and bedside monitoring of hemoglobin oxygen saturation in mixed arterial, venous, and primarily capillary blood in the tissue bed being probed. | Device | – |
Primary outcome
Cerebral and abdominal NIRS in neonates
Time frame: After birth in 20 min
Cerebral and abdominal tissue oxygen saturation was obtained using 4-wavelength (690, 780, 805 and 850nm) near-infrared spectroscopy (FORE-SIGHT, CAS Medical Systems, Branford, CT) with a transducer containing a fiber optic emitter and one detector located 25mm from the light source. A non-adhesive optode (FORE-SIGHT sensor kit small, CAS Medical Systems, Branford, CT) was placed on the left forehead and abdomen.
1 secondary outcome
Pulse oximetry in neonates
Time frame: After birth in 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Results publication: PubMed 20472937SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.
- Results publication: PubMed 23642047BOOST II United Kingdom Collaborative Group; BOOST II Australia Collaborative Group; BOOST II New Zealand Collaborative Group; Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013 May 30;368(22):2094-104. doi: 10.1056/NEJMoa1302298. Epub 2013 May 5.
- Results publication: PubMed 28067688Spaeder MC, Klugman D, Skurow-Todd K, Glass P, Jonas RA, Donofrio MT. Perioperative Near-Infrared Spectroscopy Monitoring in Neonates With Congenital Heart Disease: Relationship of Cerebral Tissue Oxygenation Index Variability With Neurodevelopmental Outcome. Pediatr Crit Care Med. 2017 Mar;18(3):213-218. doi: 10.1097/PCC.0000000000001056.
- Results publication: PubMed 25531368Schmid MB, Hopfner RJ, Lenhof S, Hummler HD, Fuchs H. Cerebral oxygenation during intermittent hypoxemia and bradycardia in preterm infants. Neonatology. 2015;107(2):137-46. doi: 10.1159/000368294. Epub 2014 Dec 20.
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.
Li Tian principal investigator
Xijing Hospital
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 Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at Birth, run by Xijing Hospital at 1 site in China.
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 3 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 11 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 China. 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?
Contact Li Tian (+86 29 84775337, tianli_fmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral and abdominal NIRS in neonates (time frame: After birth in 20 min). 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 NCT03149731, which also lists 4 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 11 May 2017.