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Completed

NCT Number: NCT03104946

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

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Morbidity;Infant Obstetric Labor Complications Obstetric Labor, Premature Outcome, Fatal Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Diagnostic Test

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

Primary outcomes

  1. cognitive delay

    Time frame: 1 year

    mental development index(MDI）<70

  2. hearing impairment

    Time frame: 1 year

    do not pass auditory brainstem response (ABR)

  3. visual impairment

    Time frame: 1 year

    do not pass okineticnystagmus

Sponsors and collaborators

Lead sponsor

yangjie

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 7, 2017
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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