Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

Preterm Infant Clinical Trial

Official title:

Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311540
• Other study ID #: ZincVLBW
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2014
• Est. completion date: April 20, 2015

Study information

• Verified date: February 2023
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.

• Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.

• Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.

• There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.

• Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Description:

Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).

Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of <32 weeks were randomly allocated on the seventh day of life 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 were feeding intolerance, NEC (stage≥2), LOS and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: April 20, 2015
• Est. primary completion date: March 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days to 9 Days

Eligibility

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

• Severe sepsis

• Previous early-onset NEC history

• Infants on the intervention arm who did not continue Zinc supplementation during the study period

• Hemodynamically unstability

• Infants nil per os

• No consent from the family

• Death before the 7th day of life

Related Conditions & MeSH terms

• Birth Weight
• Deficiency Diseases
• Effect of Drugs
• Preterm Infant

Intervention

Drug:
• Zinc Sulfate

Locations

Country	Name	City	State
Turkey	Izmir Democracy University Faculty of Medicine	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital	Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of feeding intolerance		through study completion, an average of 6 months
Secondary	Duration of hospitalization		through study completion, an average of 6 months
Secondary	Number of participants with necrotising enterocolitis (stage=2)		through study completion, an average of 6 months
Secondary	Incidence of mortality		through study completion, an average of 6 months
Secondary	Number of participants with late onset sepsis		through study completion, an average of 6 months
Secondary	Number of participants with retinopathy of prematurity		through study completion, an average of 6 months
Secondary	Number of participants with bronchopulmonary dysplasia		through study completion, an average of 6 months