Outcome of synbiotics on necrotizing enterocolitis, sepsis

Comparison of prophylactic effect of synbiotic on necrotizing enterocolitis, sepsis and hyperbilirubinemia with placebo on very low birth weight infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013062710279N3

Enrollment

210

Registered

2015-01-18

Start date

2012-10-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Necrotizing enterocolitis. Condition 2: Sepsis. Condition 3: Hyperbilirubinemia. Necrotizing enterocolitis of fetus and newborn Bacterial sepsis of newborn Neonatal jaundice from breast milk inhibitor

Interventions

Intervention 1: The intervention group received synbiotic preparation (Probiotic ATP, NBL, 1/2 sachet per dose twice daily) which were added to breast milk or formula until discharge. Intervention 2:

1 cc per dose twice daily) which were added to breast milk or formula until discharge.

Treatment - Drugs

Placebo

The intervention group received synbiotic preparation (Probiotic ATP, NBL, 1/2 sachet per dose twice daily) which were added to breast milk or formula until discharge.

The control group received placebo (distilled water

Eligibility

Sex/Gender

All

Age

1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Very low birth weight infants (gestational age: =32 weeks; birth weight: =1500 g) who survived to feed enterally (minimum age: first postnatal day, maximum age: 10 days). Exclusion criteria: Infants who had severe asphyxia (stage III), major congenital anomalies, those who had been fasted for more than 3 weeks, died within the first postnatal 14 days.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Necrotizing enterocolitis. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Sepsis. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Hyperbilirubinemia. Timepoint: Starts at the same time with the intervention. Method of measurement: Serum sample.	—

Secondary

Measure	Time frame
Weight gain per week. Timepoint: Starts on the 7th day of intervention. Method of measurement: Patients' medical records.;Time to reach full enteral feeding. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients medical records.;Mortality until hospital discharge. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Length of hospitalization. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Neurocognitive development. Timepoint: 18 months corrected age. Method of measurement: Bayley test.	—

Measure

Time frame

Weight gain per week. Timepoint: Starts on the 7th day of intervention. Method of measurement: Patients' medical records.;Time to reach full enteral feeding. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients medical records.;Mortality until hospital discharge. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Length of hospitalization. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Neurocognitive development. Timepoint: 18 months corrected age. Method of measurement: Bayley test.

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Countries

Turkey

Contacts

Public ContactFahri Ovali

Zeynep Kamil Maternity and Children's Education and Training Hospital

fovali@yahoo.com0090 216 391 06 80

Outcome results

None listed

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