Low Apgar ScoresNCT06961123
Establishment of a Longitudinal Cohort for Newborns With Low Apgar Scores at Birth
An observational study of Low Apgar Scores, run by Peking University Third Hospital at 1 site in China.
Trial summary
The objective of this study is to identify high-risk factors associated with low Apgar scores, implement proactive interventions to reduce their occurrence, and analyze neonatal resuscitation procedures and systemic treatment during hospitalization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Apgar Scores
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Newborns born at Peking University Third Hospital with Apgar scores ≤ 7 at any time point within 1 minute, 5 minutes, or 10 minutes after birth
Who may be able to join
- Retrospective cohort inclusion criteria: Newborns born between January 1, 2006 and before the start of the project at Peking University Third Hospital with Apgar scores ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
- Prospective cohort inclusion criteria: Newborns born at Peking University Third Hospital between the start of the project and December 31, 2027, with an Apgar score of ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
Who cannot join
- There are serious congenital malformations that affect physical and neurological development, and family members refuse to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
qingqing wang, 86+15101020751, wangqing01s@163.com
About this study
The objective of this study is to identify high-risk factors associated with low Apgar scores, implement proactive interventions to reduce their occurrence, and analyze neonatal resuscitation procedures and systemic treatment during hospitalization. This aims to provide evidence-based references for improving the resuscitation and medical management of newborns with low Apgar scores, thereby enhancing clinical care capabilities. Additionally, continuous follow-up management and timely intervention guidance will be provided to these infants to optimize their long-term prognosis.
Read the detailed description
This is a prospective and retrospective biphasic cohort study.Retrospective cohort inclusion criteria: Newborns born between January 1, 2006 and before the start of the project at Peking University Third Hospital with Apgar scores ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
Prospective cohort inclusion criteria: Newborns born in our hospital between the start of the project and December 31, 2027, with an Apgar score of ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
- Conditions
- Low Apgar Scores
- Keywords
- Low Apgar scores, neonatal, birth cohort
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 |
|---|---|---|
| At any time after 1 minute, 5 minutes, or 10 minutes of birth, the Apgar score of the newborn is ≤ 7 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical development indicators, Neurodevelopmental outcome
Physical development indicators：height, weight, head circumference, BMI, Z-score Neurodevelopmental outcome: Good neural development, poor neural development, cerebral palsy, autism spectrum disorder, Attention deficit hyperactivity disorder
Measured: 6 months old, 1 year old, 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start11 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Apgar ScoresStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961123
- Sponsor's protocol ID
- BYSYDL2024012
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Longitudinal Cohort for Newborns With Low Apgar Scores at Birth
- ClinicalTrials.gov ID
- NCT06961123
- Acronym / sponsor ID
- BYSYDL2024012
- Conditions
- Low Apgar Scores
- Keywords
- Low Apgar scores, neonatal, birth cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 2025 (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.
The objective of this study is to identify high-risk factors associated with low Apgar scores, implement proactive interventions to reduce their occurrence, and analyze neonatal resuscitation procedures and systemic treatment during hospitalization. This aims to provide evidence-based references for improving the resuscitation and medical management of newborns with low Apgar scores, thereby enhancing clinical care capabilities. Additionally, continuous follow-up management and timely intervention guidance will be provided to these infants to optimize their long-term prognosis.
Detailed description
This is a prospective and retrospective biphasic cohort study.Retrospective cohort inclusion criteria: Newborns born between January 1, 2006 and before the start of the project at Peking University Third Hospital with Apgar scores ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
Prospective cohort inclusion criteria: Newborns born in our hospital between the start of the project and December 31, 2027, with an Apgar score of ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At any time after 1 minute, 5 minutes, or 10 minutes of birth, the Apgar score of the newborn is ≤ 7 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborns born at Peking University Third Hospital with Apgar scores ≤ 7 at any time point within 1 minute, 5 minutes, or 10 minutes after birth
Key inclusion criteria (2 listed)
- Retrospective cohort inclusion criteria: Newborns born between January 1, 2006 and before the start of the project at Peking University Third Hospital with Apgar scores ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
- Prospective cohort inclusion criteria: Newborns born at Peking University Third Hospital between the start of the project and December 31, 2027, with an Apgar score of ≤ 7 at 1 minute, 5 minutes, or 10 minutes.
Key exclusion criteria (1 listed)
- There are serious congenital malformations that affect physical and neurological development, and family members refuse to participate in the study
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
Physical development indicators, Neurodevelopmental outcome
Time frame: 6 months old, 1 year old, 2 years old
Physical development indicators：height, weight, head circumference, BMI, Z-score Neurodevelopmental outcome: Good neural development, poor neural development, cerebral palsy, autism spectrum disorder, Attention deficit hyperactivity disorder
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Low Apgar Scores
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
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.
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 Low Apgar Scores, run by Peking University Third 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 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: looking for participants now, as of the sponsor's last update on 7 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qingqing wang (86+15101020751, wangqing01s@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical development indicators, Neurodevelopmental outcome (time frame: 6 months old, 1 year old, 2 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.