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
1 other identifier
observational
834
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedApril 7, 2017
March 1, 2017
2.2 years
March 28, 2017
April 2, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
cognitive delay
mental development index(MDI）\<70
1 year
hearing impairment
do not pass auditory brainstem response (ABR)
1 year
visual impairment
do not pass okineticnystagmus
1 year
Study Arms (8)
Bronchopulmonary Dysplasia
Retinopathy
Severe Retinopathy
Neonatal Necrotizing Enterocolitis
Brain injury
sepsis
Patent Ductus Arteriosus
Respiratory Distress Syndrome
Interventions
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
Eligibility 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 and without congenital disease.
You may qualify if:
- 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.
You may not qualify if:
- The very low birth weight infants didn't have any congenital disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- yangjielead
Related Publications (2)
Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. JAMA. 2003 Mar 5;289(9):1124-9. doi: 10.1001/jama.289.9.1124.
PMID: 12622582BACKGROUNDRao YB, Yang J, Cao B, Chen DM, Gao PM, Zhong Q, Li MX, Gao JH, Chen YJ, Zhong XM, Ren ZX. [Predictive effect of neonatal morbidities on the poor outcomes at 12 months corrected age in very low birth weight premature infants]. Zhonghua Er Ke Za Zhi. 2017 Aug 2;55(8):608-612. doi: 10.3760/cma.j.issn.0578-1310.2017.08.012. Chinese.
PMID: 28822437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Dept of Neonatology
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 7, 2017
Study Start
September 1, 2013
Primary Completion
November 30, 2015
Study Completion
November 30, 2016
Last Updated
April 7, 2017
Record last verified: 2017-03