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To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03104946
Enrollment
834
Registered
2017-04-07
Start date
2013-09-01
Completion date
2016-11-30
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidity;Infant, Outcome, Fatal, Preterm Infant

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.

Interventions

DIAGNOSTIC_TESTMental Development Index;Auditory Brainstem Response;okineticnystagmus

mental development index(MDI)\<70:cognitive delay do not pass auditory brainstem response(ABR):hearing impairment do not pass okineticnystagmus:visual impairment Patent Ductus Arteriosus

Sponsors

yangjie
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
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.

Design outcomes

Primary

MeasureTime frameDescription
cognitive delay1 yearmental development index(MDI)\<70
hearing impairment1 yeardo not pass auditory brainstem response (ABR)
visual impairment1 yeardo not pass okineticnystagmus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026