Evaluating the probiotics effect on clinical outcomes among neonates with congenital gastrointestinal anomalies requiring surgery admitted to neonatal intensive care unit

Evaluating the probiotics effect on neonates with congenital gastrointestinal anomalies requiring surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250628066283N1

Enrollment

Registered

2025-07-19

Start date

2025-07-23

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Condition 1: neonates with congenital gastrointestinal anomalies requiring. Condition 2: neonates with congenital gastrointestinal anomalies requiring. Condition 3: neonates with congenital gastrointestinal anomalies requiring. Congenital malformations of intestinal fixation Other specified congenital malformations of intestine Congenital malformation of intestine, unspecified

Interventions

Intervention 1: Neonates who receive probiotic supplementation in the form of oral drops. The supplement contains a blend of active probiotic strains and is manufactured by a reputable company. Dosage

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: neonates with congenital gastrointestinal anomalies requiring surgery

Exclusion criteria

Exclusion criteria: Presence of severe non-gastrointestinal congenital anomalies (e.g., complex cardiac malformations) Written informed consent from parents not obtained

Design outcomes

Primary

Measure	Time frame
Neonatal weight gain:Change in neonatal body weight (grams) from admission to day five post-intervention, measured daily at a fixed time using calibrated digital infant scales. Timepoint: Change in neonatal body weight:Measured on the day of birth and at discharge using calibrated digital infant scales. Method of measurement: Change in neonatal weight:Neonatal weight will be measured at two specific time points—at birth and at the time of discharge—using a calibrated digital infant scale with a minimum accuracy of five grams. The device will be verified and approved by the hospital’s biomedical engineering unit.;Length of hospital stay:Number of hospitalization days from the date of NICU admission until discharge. Timepoint: Length of hospital stay:Continuously recorded from the date of NICU admission until the day of discharge (final value documented at discharge). Method of measurement: Length of hospital stay:The number of hospitalization days will be determined from the date of neonatal admission to the neonatal intensive care unit until the date of discharge, based on daily entries in the electronic medical record system.;Final discharge outcome:Discharge status categorized as "with complication" or "without complication," based on clinical documentation in the medical records at the time of discharge. Timepoint: Final discharge status (with or without complication):Documented on the day of discharge based on clinical records. Method of measurement: Discharge status (with or without complication): Assessment and documentation of the neonate's final discharge status regarding the presence or absence of medical complications, based on clinical notes recorded by the attending physician in the medical file and final discharge report.	—

Measure

Time frame

Neonatal weight gain:Change in neonatal body weight (grams) from admission to day five post-intervention, measured daily at a fixed time using calibrated digital infant scales. Timepoint: Change in neonatal body weight:Measured on the day of birth and at discharge using calibrated digital infant scales. Method of measurement: Change in neonatal weight:Neonatal weight will be measured at two specific time points—at birth and at the time of discharge—using a calibrated digital infant scale with a minimum accuracy of five grams. The device will be verified and approved by the hospital’s biomedical engineering unit.;Length of hospital stay:Number of hospitalization days from the date of NICU admission until discharge. Timepoint: Length of hospital stay:Continuously recorded from the date of NICU admission until the day of discharge (final value documented at discharge). Method of measurement: Length of hospital stay:The number of hospitalization days will be determined from the date of neonatal admission to the neonatal intensive care unit until the date of discharge, based on daily entries in the electronic medical record system.;Final discharge outcome:Discharge status categorized as "with complication" or "without complication," based on clinical documentation in the medical records at the time of discharge. Timepoint: Final discharge status (with or without complication):Documented on the day of discharge based on clinical records. Method of measurement: Discharge status (with or without complication): Assessment and documentation of the neonate's final discharge status regarding the presence or absence of medical complications, based on clinical notes recorded by the attending physician in the medical file and final discharge report.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegar Faramarzi Khangah

Oroumia University of Medical Sciences

sahand.urdum@yahoo.com+98 41 3666 1538

Outcome results

None listed

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