Establishment of a Longitudinal Cohort for Newborns With Low Apgar Scores at Birth

Recruiting

• Conditions: Low Apgar Scores

• Registration Number: NCT06961123
• Lead Sponsor: Peking University Third Hospital

Brief 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. 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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-11
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 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.

Exclusion Criteria

• There are serious congenital malformations that affect physical and neurological development, and family members refuse to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical development indicators, Neurodevelopmental outcome	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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China