Effect of oral probiotic supplementation on the rate of hospital acquired infection and necrotizing enterocolitis in preterm very low birth weight infants

Nosocomial infections and necrotizing enterocolitis in preterm very low birth weight neonates treated with lactobacillus acidophilus and bifidobacterium infantis in an intensive care unit : a randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39142169

Enrollment

160

Registered

2011-04-28

Start date

2005-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Hospital acquired infection and necrotizing enterocolitis in neonates Infections and Infestations Hospital acquired infection and necrotizing enterocolitis

Interventions

Daily enteral probiotic supplementation of live Lactobacillus acidophilus and Bifidobacterium infantis at a dose of 2.5 x 108 CFU of each strain once a day for at least 28 days versus placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. VLBW preterm infants (gestational age (GA) < 35 weeks , body weight (BW) < 1.5 kg) 2. Admitted to the neonatal intensive care unit (NICU) who survived the first 3 days of life

Exclusion criteria

Exclusion criteria: 1. Infants with chromosome abnormality 2. Infants with severe congenital defects 3. Infants with gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction) 4. Infants with unstable hemodynamic status

Design outcomes

Primary

Measure	Time frame
Nosocomial Infections	—

Secondary

Measure	Time frame
1. Necrotizing enterocolitis (NEC) 2. Feeding tolerance 3. Time to reach full enteral feeding	—

Countries

Thailand

Outcome results

None listed

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