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

Preterm Infant Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104946
• Other study ID #: Guangdong WCH
• Status: Completed
• Phase: N/A
• First received: March 28, 2017
• Last updated: April 2, 2017
• Start date: September 1, 2013
• Est. completion date: November 30, 2016

Study information

• Verified date: March 2017
• Source: Guangdong Women and Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Morbidity;Infant
• Outcome, Fatal
• Premature Birth
• Preterm Infant

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
yangjie

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive delay	mental development index(MDI)<70	1 year
Primary	hearing impairment	do not pass auditory brainstem response (ABR)	1 year
Primary	visual impairment	do not pass okineticnystagmus	1 year