Neonatal DiseaseNCT05468515
Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas
An observational study of Neonatal Disease and Altitude Hypoxia, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. Read more about this study
- Who is it for?
- Ages 0 to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disease, Altitude Hypoxia
- What is being tested?
- pulse oxygen saturation
- How many people
- 956 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 27 Feb 2023
- 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 0 to 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study included infants with a gestational age between 35 to 42 weeks who were born alive and appearing well
Who may be able to join
- Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:
- normal vital signs (heart rate ranging from 110 to 180 beats/minute, respiratory rate ranging from 30 to 60 breaths/minute, temperature ranging from 36.5°C to 37.5°C),
- absence of signs of illness such as respiratory distress.
- the mothers resided in the study area.
Who cannot join
- outborn, require resuscitative interventions at birth beyond blow-by oxygen,
- require admission for any reason other than observation or had a major congenital anomaly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas: a Multicenter Prospective Study
Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. During postnatal transition, pulmonary pressure decreases upon the activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of partial oxygen pressure, which is negatively correlated with altitude. As a result, postnatal transition may be different at high altitudes. Umbilical cord blood gas analysis is now recommended in all high-risk deliveries because of its' value in providing information about preceding fetal hypoxic stress. But there are only limited studies about the SpO2 measurements during the first few hours after birth and umbilical blood gas analysis at high altitudes, especially at altitudes above 2500m. The primary outcome of the study is to determine the reference intervals for preductal oxygen saturation during first 2 hours of life stratified by different gestational age. The secondary outcomes is to establish the pH and lactate cutoff value of umbilical arterial blood gas at different altitude level.
- Conditions
- Neonatal Disease, Altitude Hypoxia
- Being tested
- pulse oxygen saturation
- Keywords
- pulse oxygen saturation, neonate, altitude, umbilical arterial blood gas
- Medical subject headings
- Infant, Newborn, Diseases, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse oxygen saturationDiagnostic test
Also called umbilical blood gas analysis
preductal oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| High altitude group | altitude level range from 2500 to 4500 meters Receives: Diagnostic Test: pulse oxygen saturation | |
| mild altitude group | altitude level range from 500 to 2500 meters Receives: Diagnostic Test: pulse oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse oxygen saturation
preductal pulse oxygen saturation during first two hours after birth
Measured: during first 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start15 Mar 2022
- Primary completion10 Oct 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neonatal DiseaseStudies 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
- 956 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468515
- Sponsor's protocol ID
- 2021-03-146-K01
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2022
- Last updated
- 5 Jun 2023
- Results posted
- No
- Individual data sharing
- No
Publications
Hu XJ, Ma XJ, Zhao QM, Yan WL, Ge XL, Jia B, Liu F, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Zhai XW, Huang GY. Pulse Oximetry and Auscultation for Congenital Heart Disease Detection. Pediatrics. 2017 Oct;140(4):e20171154. doi: 10.1542/peds.2017-1154.
PubMed 28939700Tekgunduz KS, Bilen M, Kara M, Laloglu F, Ceviz N. Oxygen saturation and perfusion index screening in neonates at high altitudes: can PDA be predicted? Eur J Pediatr. 2021 Jan;180(1):31-38. doi: 10.1007/s00431-020-03698-1. Epub 2020 Jun 5.
PubMed 32504134Gonzales GF, Salirrosas A. Arterial oxygen saturation in healthy newborns delivered at term in Cerro de Pasco (4340 m) and Lima (150 m). Reprod Biol Endocrinol. 2005 Sep 12;3:46. doi: 10.1186/1477-7827-3-46.
PubMed 16156890Zamudio S, Torricos T, Fik E, Oyala M, Echalar L, Pullockaran J, Tutino E, Martin B, Belliappa S, Balanza E, Illsley NP. Hypoglycemia and the origin of hypoxia-induced reduction in human fetal growth. PLoS One. 2010 Jan 1;5(1):e8551. doi: 10.1371/journal.pone.0008551.
PubMed 20049329Toth B, Becker A, Seelbach-Gobel B. Oxygen saturation in healthy newborn infants immediately after birth measured by pulse oximetry. Arch Gynecol Obstet. 2002 Apr;266(2):105-7. doi: 10.1007/s00404-001-0272-5.
PubMed 12049291Bakr AF, Habib HS. Normal values of pulse oximetry in newborns at high altitude. J Trop Pediatr. 2005 Jun;51(3):170-3. doi: 10.1093/tropej/fmi026. Epub 2005 Apr 26.
PubMed 15855304Ogik V, Muyingo M, Musooko M, Nankunda J. Umbilical artery lactate levels and associated maternal and newborn characteristics at Mulago National Referral Hospital: a cross-sectional observational study. BMJ Open. 2021 Aug 26;11(8):e043827. doi: 10.1136/bmjopen-2020-043827.
PubMed 34446476Bellera CA, Hanley JA. A method is presented to plan the required sample size when estimating regression-based reference limits. J Clin Epidemiol. 2007 Jun;60(6):610-5. doi: 10.1016/j.jclinepi.2006.09.004. Epub 2007 Jan 16.
PubMed 17493520
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas: a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT05468515
- Acronym / sponsor ID
- 2021-03-146-K01
- Conditions
- Neonatal Disease, Altitude Hypoxia
- Keywords
- pulse oxygen saturation, neonate, altitude, umbilical arterial blood gas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 956 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 21 Jul 2022 (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.
Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. During postnatal transition, pulmonary pressure decreases upon the activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of partial oxygen pressure, which is negatively correlated with altitude. As a result, postnatal transition may be different at high altitudes. Umbilical cord blood gas analysis is now recommended in all high-risk deliveries because of its' value in providing information about preceding fetal hypoxic stress. But there are only limited studies about the SpO2 measurements during the first few hours after birth and umbilical blood gas analysis at high altitudes, especially at altitudes above 2500m. The primary outcome of the study is to determine the reference intervals for preductal oxygen saturation during first 2 hours of life stratified by different gestational age. The secondary outcomes is to establish the pH and lactate cutoff value of umbilical arterial blood gas at different altitude level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High altitude group | – | Diagnostic Test: pulse oxygen saturationaltitude level range from 2500 to 4500 meters |
| mild altitude group | – | Diagnostic Test: pulse oxygen saturationaltitude level range from 500 to 2500 meters |
Who may qualify
- Ages
- 0 to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study included infants with a gestational age between 35 to 42 weeks who were born alive and appearing well
Key inclusion criteria (4 listed)
- Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:
Key exclusion criteria (2 listed)
- outborn, require resuscitative interventions at birth beyond blow-by oxygen,
- require admission for any reason other than observation or had a major congenital anomaly.
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 |
|---|---|---|
| pulse oxygen saturationAlso: umbilical blood gas analysispreductal oxygen saturation | Diagnostic test | High altitude group, mild altitude group |
Primary outcome
pulse oxygen saturation
Time frame: during first 2 hours after birth
preductal pulse oxygen saturation during first two hours after 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 5 Jun 2023.
- Background: PubMed 28939700Hu XJ, Ma XJ, Zhao QM, Yan WL, Ge XL, Jia B, Liu F, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Zhai XW, Huang GY. Pulse Oximetry and Auscultation for Congenital Heart Disease Detection. Pediatrics. 2017 Oct;140(4):e20171154. doi: 10.1542/peds.2017-1154.
- Background: PubMed 32504134Tekgunduz KS, Bilen M, Kara M, Laloglu F, Ceviz N. Oxygen saturation and perfusion index screening in neonates at high altitudes: can PDA be predicted? Eur J Pediatr. 2021 Jan;180(1):31-38. doi: 10.1007/s00431-020-03698-1. Epub 2020 Jun 5.
- Background: PubMed 16156890Gonzales GF, Salirrosas A. Arterial oxygen saturation in healthy newborns delivered at term in Cerro de Pasco (4340 m) and Lima (150 m). Reprod Biol Endocrinol. 2005 Sep 12;3:46. doi: 10.1186/1477-7827-3-46.
- Background: PubMed 20049329Zamudio S, Torricos T, Fik E, Oyala M, Echalar L, Pullockaran J, Tutino E, Martin B, Belliappa S, Balanza E, Illsley NP. Hypoglycemia and the origin of hypoxia-induced reduction in human fetal growth. PLoS One. 2010 Jan 1;5(1):e8551. doi: 10.1371/journal.pone.0008551.
- Background: PubMed 12049291Toth B, Becker A, Seelbach-Gobel B. Oxygen saturation in healthy newborn infants immediately after birth measured by pulse oximetry. Arch Gynecol Obstet. 2002 Apr;266(2):105-7. doi: 10.1007/s00404-001-0272-5.
- Background: PubMed 15855304Bakr AF, Habib HS. Normal values of pulse oximetry in newborns at high altitude. J Trop Pediatr. 2005 Jun;51(3):170-3. doi: 10.1093/tropej/fmi026. Epub 2005 Apr 26.
- Background: PubMed 34446476Ogik V, Muyingo M, Musooko M, Nankunda J. Umbilical artery lactate levels and associated maternal and newborn characteristics at Mulago National Referral Hospital: a cross-sectional observational study. BMJ Open. 2021 Aug 26;11(8):e043827. doi: 10.1136/bmjopen-2020-043827.
- Background: PubMed 17493520Bellera CA, Hanley JA. A method is presented to plan the required sample size when estimating regression-based reference limits. J Clin Epidemiol. 2007 Jun;60(6):610-5. doi: 10.1016/j.jclinepi.2006.09.004. Epub 2007 Jan 16.
- Individual participant dataSharing planned: No
Related trials for Neonatal Disease
Active, not recruiting
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Rett Syndrome
RecruitingObservational study
Feasibility Study of a Chatbot AI-Driven Preliminary Screening System for Hereditary Cancer Syndromes
Hereditary Cancer Syndromes
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neonatal Disease and Altitude Hypoxia, run by Children's Hospital of Fudan University 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 4 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: finished, as of the sponsor's last update on 5 Jun 2023. 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?
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?
pulse oxygen saturation (time frame: during first 2 hours after birth). 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 NCT05468515, which also lists 8 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 5 Jun 2023.