Randomised controlled trial of probiotics for preterm and small for gestational age infants

Efficacy of probiotic supplementation in preterm and small for gestational age infants: a multi-centre, placebo-controlled, individually-randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12028895

Enrollment

14000

Registered

2025-04-08

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Improvement in health outcomes (survival, necrotising enterocolitis, infections and growth) Other

Interventions

1. Screening, assessment of eligibility, enrolment: 1.1. Screening: Hospital staff (i.e. the doctors and nurses in the hospital who are routinely caring for mothers during labour and babies after birt

Eligibility

Sex/Gender

All

Age

0 Days to 2 Days

Inclusion criteria

Inclusion criteria: 1. <48 hours of age at the time of enrolment 2. Preterm (appropriate for gestational age [AGA] or small for gestational age [SGA]) or term SGA infants 3. Likely to be in the study area for the next 6 months

Exclusion criteria

Exclusion criteria: 1. <28 weeks gestation 2. Not taking enteral feeds (e.g. due to a major congenital abnormality, mechanically ventilated, post-surgery or too unwell to be fed) 3. Confirmed sepsis at the time of enrolment 4. Indwelling central lines (including umbilical catheter/central venous line) (infants with peripheral intravenous lines will not be excluded) 5. Multiple births (e.g. twins, triplets)

Design outcomes

Primary

Measure	Time frame
Measured from enrolment to 6 months of age: 1. Preterm infants: all-cause mortality measured using: 1.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 1.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants 2. Term SGA infants: underweight-free survival: proportion of infants with weight for age z score (WAZ) >=-2 standard deviations (SD) who have not died, measured using: 2.1. Death: 2.1.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 2.1.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants 2.2. Underweight: weight measurement taken by trained field workers	—

Measure

Time frame

Measured from enrolment to 6 months of age: 1. Preterm infants: all-cause mortality measured using: 1.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 1.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants 2. Term SGA infants: underweight-free survival: proportion of infants with weight for age z score (WAZ) >=-2 standard deviations (SD) who have not died, measured using: 2.1. Death: 2.1.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 2.1.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants 2.2. Underweight: weight measurement taken by trained field workers

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Secondary

Measure	Time frame
Mortality and morbidity measured at hospital discharge, 1 month and 6 months of age: 1. All-cause mortality (for the 6-month endpoint, this will be evaluated as a secondary outcome for term SGA infants, and as a primary outcome for preterm infants) measured using: 1.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 1.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants 2. Cause-specific mortality due to necrotising enterocolitis, sepsis, or severe diarrhoea measured using: 2.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 2.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants Plus cause due to necrotising enterocolitis, sepsis, or severe diarrhoea confirmed by the trial adjudication committee 3. Incidence of suspected necrotising enterocolitis (modified Bells grade 2 or greater criteria) measured using: 3.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 3.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants Plus cause confirmed by the trial adjudication committee 4. Episodes of suspected sepsis: incidence of suspected sepsis measured using: 4.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 4.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants Plus cause confirmed by the trial adjudication committee 5. Episodes of confirmed sepsis: incidence of suspected sepsis with bacterial pathogens isolated from blood cultures: 5.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow up visits 5.2. Event ascertained by trained field worker during daily hospital	—

Measure

Time frame

Mortality and morbidity measured at hospital discharge, 1 month and 6 months of age: 1. All-cause mortality (for the 6-month endpoint, this will be evaluated as a secondary outcome for term SGA infants, and as a primary outcome for preterm infants) measured using: 1.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 1.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants 2. Cause-specific mortality due to necrotising enterocolitis, sepsis, or severe diarrhoea measured using: 2.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 2.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants Plus cause due to necrotising enterocolitis, sepsis, or severe diarrhoea confirmed by the trial adjudication committee 3. Incidence of suspected necrotising enterocolitis (modified Bells grade 2 or greater criteria) measured using: 3.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 3.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants Plus cause confirmed by the trial adjudication committee 4. Episodes of suspected sepsis: incidence of suspected sepsis measured using: 4.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow-up visits 4.2. Event ascertained by trained field worker during daily hospital review of hospitalised infants Plus cause confirmed by the trial adjudication committee 5. Episodes of confirmed sepsis: incidence of suspected sepsis with bacterial pathogens isolated from blood cultures: 5.1. Mother’s recall of event in the previous 4 weeks reported to trained field workers during scheduled follow up visits 5.2. Event ascertained by trained field worker during daily hospital

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Countries

Bangladesh, Ethiopia, Kenya, Nigeria, Pakistan

Contacts

Public ContactSachiyo Yoshida

yoshidas@who.int+41 (0)227912111

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026