Effect of Zinc Supplementation on Neonatal Mortality and Morbidities in Very Low Birth Weight Infants
Study Details
Study Description
Brief Summary
Zinc is a mineral which has multiple vital roles in many reactions in human body including essential metabolic pathways apart from being an important element in human body. 60% of Zinc passes to the fetus through placenta during the third trimester. Besides, preterm infants lack the capability of absorbing and keeping Zinc in their bodies. These babies obviously need high amounts of Zinc. High dose Zinc is hypothesized to have pharmacologic effects besides supplying the physiological needs. Previous studies did not reveal any adverse effects due to relatively high dose Zinc. In this study the investigators aimed to investigate the effect of high dose Zinc supplementation on neonatal mortality and morbidities in VLBW(very low birth weight) infants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Background: Preterm infants have high requirements of Zn and are generally believed to be in a negative Zn balance in the early period of life.
Objective: To investigate the effect of high doze zinc supplementation in very low birth weight infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).
Study design and Methods: This is a prospective randomized trial. Preterm infants >7 days old with gestational age of <32 weeks and birth weight of <1500 g were randomly allocated to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge.
Outcome measures: Feeding intolerance, NEC (stage≥2), LOS and mortality.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Zinc intervention 9 mg/day Zinc suspension via og tube, started on day 7 until discharge from hospital |
Drug: Zinc Sulfate
|
| No Intervention: Control No supplementation is given |
Outcome Measures
Primary Outcome Measures
- change in incidence of feeding intolerance [through study completion, an average of 6 months]
- change in incidence of late onset sepsis [through study completion, an average of 6 months]
- change in mortality rate [through study completion, an average of 6 months]
- change in incidence of Necrotising Enterocolitis [through study completion, an average of 6 months]
Secondary Outcome Measures
- change in duration of hospitalization [through study completion, an average of 6 months]
- change in time to reach full enteral feeds [through study completion, an average of 6 months]
- change in duration to reach birth weight [an average of 1 month]
- change in neurodevelopmental scores [an average of 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
< 32 weeks gestational age and/or <1500 gr birth weight
-
Born in the study hospital
-
Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient
Exclusion Criteria:
-
Major Congenital malformations and/or critical congenital heart defects
-
Born in another hospital
-
Severe birth asphyxia
-
Babies on the intervention arm who did not continue Zinc supplementation during the study period
-
No consent from the family
-
Death before the 7th day of life
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aydin Maternity and Childrens' Hospital | Aydın | Turkey | 09020 |
Sponsors and Collaborators
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Ankara City Hospital Bilkent
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZincVLBW