Clinical trial NCT05311540: Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
Official title: Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Infant
Effect of Drugs
Zinc Deficiency Disease
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2022-04-05
Enrollment: 195
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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
* 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

Primary outcomes:
measure: Incidence of feeding intolerance
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: through study completion, an average of 6 months
measure: Number of participants with necrotising enterocolitis (stage≥2)
timeFrame: through study completion, an average of 6 months
measure: Incidence of mortality
timeFrame: through study completion, an average of 6 months
measure: Number of participants with late onset sepsis
timeFrame: through study completion, an average of 6 months
measure: Number of participants with retinopathy of prematurity
timeFrame: through study completion, an average of 6 months
measure: Number of participants with bronchopulmonary dysplasia
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Democracy University Faculty of Medicine
Study officials:
References: