Status:
WITHDRAWN
Efficacy of Multiple Strain Probiotics Reduces the Neurobehavioral Disorder in Premature Very Low Birth Weight Infants
Lead Sponsor:
China Medical University Hospital
Conditions:
Very Low Birth Weight Infants
Eligibility:
All Genders
Phase:
NA
Brief Summary
The management protocols, clinical practices, equipment, infrastructure, and key personnel in NICU are unchanged during the study period. The data collected by each center are transmitted to the offic...
Detailed Description
Over the years, preterm very low birth weight (PVLBW) infants (\<32 weeks gestation) have better survival rates and improved outcomes. Nonetheless, It is of concern that there are increased risk of ps...
Eligibility Criteria
Inclusion
- Preterm infants ≧ 23 weeks and ≦ 32 weeks gestational age.
- Birth weight below 1500 gm and who survive to NICU.
Exclusion
- Severe asphyxia (stage III)
- Fetal chromosomal anomalies
- Cyanotic congenital heart disease
- Congenital intestinal atresia
- Gastroschisis
- Omphalocele
- Active upper gastric intestinal bleeding
- Lacking/refused of parental consent
- Early onset sepsis (before the third day of life)
- Liver failure (aspartate aminotransferase, alanine aminotransferase, glutamyl transferase, direct bilirubin serum values 3-fold higher than reference range)
- Fasted for \>3 weeks.
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03858816
Start Date
June 14 2018
End Date
June 30 2021
Last Update
March 21 2022
Active Locations (1)
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1
Department of Pediatrics, Children Hospital, China Medical University
Taichung, Taiwan, 404