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

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 Overview

• Status: Completed
• Conditions: Outcome, Fatal; Preterm Infant; Morbidity;Infant
• Intervention / Treatment: Diagnostic test: Mental Development Index;Auditory Brainstem Response;okineticnystagmus

• Study Type: Observational
• Enrollment (Actual): 834

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sepsis	Diagnostic test: Mental 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
Bronchopulmonary Dysplasia	Diagnostic test: Mental 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
Retinopathy	Diagnostic test: Mental 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
Severe Retinopathy	Diagnostic test: Mental 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
Neonatal Necrotizing Enterocolitis	Diagnostic test: Mental 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
Brain injury	Diagnostic test: Mental 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
Patent Ductus Arteriosus	Diagnostic test: Mental 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
Respiratory Distress Syndrome	Diagnostic test: Mental 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: yangjie

Publications and helpful links

General Publications

• 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.
• Rao 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 2, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: Guangdong WCH

Drug and device information, study documents

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