Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China

Care practices, mortality and morbidity of very premature infants from two different tertiary centers were collected and compared, in order to discover areas for improvement where these two newborn centers can learn from each other.

Study Overview

• Status: Completed
• Conditions: Morbidity;Newborn; Morality; Very Preterm Maturity of Infant
• Intervention / Treatment: Other

Detailed Description

This retrospective cohort study was conducted in two hospitals,Qinghai Red Cross Hospital and Jinan University affiliated Shenzhen Baoan Women's and Children's Hospital.Very premature infants born with a gestational age between 22+0 - 31+6 weeks admitted to both centers during 3 years from January 1, 2018 to December 31, 2020 were studied. In both centers, data including maternal characteristics, neonatal characteristics, obstetric practices, delivery room practices, and neonatal outcomes, were collected by data abstractors in each NICU. Anonymous data was transferred to Shenzhen and analyses were performed at the newborn center of SZH.

• Study Type: Observational
• Enrollment (Actual): 807

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Shenzhen Baoan Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Very premature infants born with a gestational age between 22+0 - 31+6 weeks admitted to newborn centers of Qinghai Red Cross Hospital and Shenzhen Baoan Women's and Children's Hospital from Jan 1, 2018 to Dec 31, 2020.

Description

Inclusion Criteria:

• Very premature infants born with a gestational age between 22+0 - 31+6 weeks；
• Admitted to both centers during 3 years from January 1, 2018 to December 31, 2020.

Exclusion Criteria:

• Infants not born at QHH or SZH (out born);
• Infants who had major congenital anomalies;
• Infants admitted after 7 days of life.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Qinghai Red Cross Hospital
Shenzhen Baoan Women's and Children's Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	death during hospitalisation and death after withdrawing treatment	Jan 1,2018 - Dec 31,2020
Major morbidity	severe neurological injury, moderate to severe BPD, NEC or severe ROP	Jan 1,2018 - Dec 31,2020

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 31, 2021
• First Submitted That Met QC Criteria: October 31, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: mortality; comparison; morbidity; care practices; very preterm infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NMU-FY2021-58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No