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

NCT ID: NCT03104946

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

834 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Infant Morbidity;Infant Outcome, Fatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bronchopulmonary Dysplasia

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Retinopathy

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Severe Retinopathy

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Neonatal Necrotizing Enterocolitis

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Brain injury

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

sepsis

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Patent Ductus Arteriosus

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Respiratory Distress Syndrome

Mental Development Index;Auditory Brainstem Response;okineticnystagmus

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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yangjie

OTHER

Sponsor Role lead

Responsible Party

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yangjie

Director of Dept of Neonatology

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 12622582 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28822437 (View on PubMed)

Other Identifiers

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Guangdong WCH

Identifier Type: -

Identifier Source: org_study_id

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