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Investigating the effect of probiotics on the outcomes of very preterm infants hospitalized in the neonatal intensive care unit

Evaluating the effect of probiotics on the outcomes of very preterm infants hospitalized in the neonatalbintensive care unit of Shahid sadoughi hospital,Yazd:a double_blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190911044744N6
Enrollment
60
Registered
2024-05-28
Start date
2024-05-04
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Evaluating the effect of probiotics on the rate of growth , weight gain , NEC , Investigating sepsis in very preterm infants.

Interventions

Intervention 1: Intervention group: Recipients of Pedi Lact Probiotic drops in the first 14 days after birth, when the baby can tolerate milk, we start 5 drops as prophylaxis and continue for at leas

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Months to 7 Months

Inclusion criteria

Inclusion criteria: Very preterm infants less than 32 weeks Very preterm infants less than 1500 grams weight Very preterm infants between 28 and 32 weeks(28_32)

Exclusion criteria

Exclusion criteria: Infants who have gastrointestinal abnormalities such as various obstructions Infants who need gastrointestinal surgery (such as: esophageal atresia, duodenum, gastroschisis) Infants over 32 weeks / over 1500 grams Asphyxiated infants

Design outcomes

Primary

MeasureTime frame
Investigating the rate of growth of the infants based on grams, Investigating sepsis based on whether it is positive or not, Investigating the rate of NEC (necrotizing enterocolitis) based on whether it is positive or not, The duration of hospitalization is recorded and checked. Timepoint: The first 14 days after birth, when the baby can tolerate milk. Method of measurement: The level of sepsis is determined based on blood culture, platelet count, WBC count, and CRP level. The level of NEC (necrotizing enterocolitis) is determined based on clinical and radiological findings. The hospitalization rate is found in the file based on the duration of the baby's hospitalization day. Growth indices are recorded based on weight in grams, height in centimeters, and head circumference in centimeters from the time of admission to discharge.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Mirzaei

Yazd University of Medical Sciences

Ehsan.mirzaei.1369@gmail.com+98 35 3820 3419

Outcome results

None listed

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