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Clinical Trials/NCT03104946
NCT03104946CompletedNot Applicable

Clinical Research on the Predictive Effect of Neonatal Morbidities on the Poor Outcomes to Very Low Birth-weight and Extremely Low Birth-weight Infants

yangjie0 sites834 target enrollmentStarted: September 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
834
Primary Endpoint
visual impairment

Study Overview

Brief Summary

From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death, cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to observe the relationship between morbidities and poor outcomes. And the predictive effect on the number of the top three morbidities were analyzed by Logistic regression analysis.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
1 Month to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g.

Exclusion Criteria

  • The very low birth weight infants didn't have any congenital disease.

Outcomes

Primary Outcomes

visual impairment

Time Frame: 1 year

do not pass okineticnystagmus

cognitive delay

Time Frame: 1 year

mental development index(MDI)\<70

hearing impairment

Time Frame: 1 year

do not pass auditory brainstem response (ABR)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
yangjie
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

yangjie

Director of Dept of Neonatology

Guangdong Women and Children Hospital

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