The efficacy of probiotics for prevention of necrotising enterocolitis in very low birth weight infants: a randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67165178

Enrollment

630

Registered

2007-08-17

Start date

2007-09-01

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

Necrotising enterocolitis in very low birth weight infants. Digestive System Necrotising enterocolitis

Interventions

The participants will be randomised into two groups of 315 infants: Control group: 3 ml of pasteurised human milk once a day on the second to the 30th day of life, or at the discharge if it happens

Eligibility

Inclusion criteria

Inclusion criteria: Infants with birth weight from 750 g to 1500 g admitted in the Neonatal intensive Care Unit of the Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]).

Exclusion criteria

Exclusion criteria: 1. Newborns with severe congenital malformations 2. Newborns with severe chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
To compare the frequency of the necrotising enterocolitis classified as higher or equal to 2 according to Bell?s criteria modified by Walsh and Kleigman during the first 30 days of life.	—

Secondary

Measure	Time frame
1. To compare the frequency of pathogenic bacteria in the faeces tested weekly during the first month of life, in neonates treated with or without antibiotics; collecting stool samples (rectal swab) on 1, 7, 14 and 30 days of life, under sterile conditions and immediately transported to the bacteriology laboratory situated in the same building for processing 2. To compare the duration of birth weight recovery; assessment of the weight of the infants daily during the hospital stay 3. To compare the time taken to reach full enteral feeds - defined as a daily intake of 120 ml/Kg; across the diary registration of the enteral feeds volumes during the hospital stay 4. To compare the duration of hospital stay; the time between the admission and the discharge	—

Measure

Time frame

1. To compare the frequency of pathogenic bacteria in the faeces tested weekly during the first month of life, in neonates treated with or without antibiotics; collecting stool samples (rectal swab) on 1, 7, 14 and 30 days of life, under sterile conditions and immediately transported to the bacteriology laboratory situated in the same building for processing 2. To compare the duration of birth weight recovery; assessment of the weight of the infants daily during the hospital stay 3. To compare the time taken to reach full enteral feeds - defined as a daily intake of 120 ml/Kg; across the diary registration of the enteral feeds volumes during the hospital stay 4. To compare the duration of hospital stay; the time between the admission and the discharge

—

Countries

Brazil

Outcome results

None listed

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