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Zinc supplementation in very low birth weight neonates

Phase 3
Recruiting
Conditions
Morbidity in very low birth weight neonates
Intraventricular hemorrhage
Retinopathy of prematurity
Diet and Nutrition - Other diet and nutrition disorders
sepsis
Necrotizing enterocolitis
Bronchopulmonary dysplasia
Reproductive Health and Childbirth - Complications of newborn
Oral and Gastrointestinal - Normal oral and gastrointestinal development and function
Registration Number
ACTRN12612000823875
Lead Sponsor
V.Betania” Evangelic Hospital of Naples
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
200
Inclusion Criteria

Newborns with birth weight 401-1500 g or gestational age 24-32 weeks, consecutively observed in Neonatal Intensive Care Units

Exclusion Criteria

congenital or maternal infections, immunodeficiency, malformations, syndrome, genetic defects, evidence of infections and NEC before enrolment, critically ill condition (blood pH < 6.8, or hypoxia with persistent bradycardia for at least 1 hour), and hospitalization less than 1 week

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The morbidity of very low birth weight newborns treated with zinc. Morbidity was defined by the presence of at least one of the following conditions: BPD, IVH, NEC, sepsis, and ROP[Morbidity of neonates during hospitalization]
Secondary Outcome Measures
NameTimeMethod
mortality[Mortality of neonates during hospitalization]
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