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The effect of early onset of oral zinc supplementation in preterm infants 28 to 34 weeks

Evaluation of the effect of early onset of oral zinc supplementation in preterm infants 28 to 34 weeks in Imam Reza Hospital

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001162N27
Enrollment
100
Registered
2022-03-02
Start date
2021-11-22
Completion date
Unknown
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of premature infants. Preterm [premature] newborn [other]

Interventions

Intervention 1: Intervention group: They will receive 0.5 cc/kg (neo zinc brand) of zinc syrup daily oral for 15 days. Intervention 2: Control group: They receive distilled water 0.5 cc/kg daily oral

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Infants with birth weight 1000 to 1800 grams Gestational age 28-34 weeks

Exclusion criteria

Exclusion criteria: Dissatisfaction of parents Any suspicion of moderate to severe asphyxia based on asphyxia symptoms in premature infants Any congenital defects of the gastrointestinal tract Ichthyosis and congenital skin defects History of intrauterine infection in the infant Maternal infection and maternal chorioamnionitis before delivery Long-term PROM in the mother

Design outcomes

Primary

MeasureTime frame
Newborn weight gain. Timepoint: Infants are weighted daily throughout hospitalization and weighted each week after discharge until the end of one month. Method of measurement: Scale.

Secondary

MeasureTime frame
Evaluation of delayed sepsis in infancy. Timepoint: By performing tests at the time of hospitalization and at any time the baby has suspicious symptoms of sepsis. Method of measurement: Examination for leukocytosis (WBC greater than 15,000) or leukopenia (WBC less than 5,000) or thrombocytopenia (PLT less than 150,000) Sepsis will be checked and antibiotics will be changed according to the baby's routine treatment. In this study, only the presence of sepsis will be investigated.;Evaluation of cerebral hemorrhage in infants. Timepoint: At the end of the first week, the babies will have a routine brain ultrasound, and during the hospitalization, an ultrasound will be performed whenever the patient has suspicious symptoms of hemorrhage. Method of measurement: Brain ultrasound.;Measurement of serum zinc levels at the end of the first week in all infants. Timepoint: At the end of the first week. Method of measurement: Testing.;Evaluation of NEC in preterm infants of both groups. Timepoint: Necessary diagnostic and therapeutic measures, including ultrasound and abdominal x-rays and antibiotic therapy, will be initiated whenever the necropsy is suspected of having NEC. Method of measurement: Ultrasound and abdominal x-rays.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMorteza Rasti

Mashhad University of Medical Sciences

rastism991@mums.ac.ir+98 51 3852 1121

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026