:The effect of buccal colostrum administration on outcome of preterm neonates: A randomized-controlled trial

The effect of buccal colostrum administration on outcome of preterm neonates: A randomized-controlled trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202505637349592

Enrollment

Registered

2025-05-06

Start date

2025-03-15

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Digestive System Neonatal spsis Neonatal Diseases

Interventions

Only routine Care of the newborn admitted in NICU without administration of buccal colostrum

Buccal mucosa colostrum administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants (< 32 weeks) and whose body weights < 1500gm

Exclusion criteria

Exclusion criteria: 1.Conditions at which breast milk is contraindicated including active tuberculosis or AIDS, treatment with radioisotopes (e.g., Iodine- 131, Cobalt-60, Cesium- 137), substance abuse or treatment with special medications excreted in breast milk, such as antimetabolic anticarcinoma agents (e.g., azathioprine,methotrexate, rituximab) or antipsychotics (e.g., lithium carbonate, clozapine); 2. Neonates with severe gastrointestinal malformation or severe fatal disabling congenital chromosomal abnormalities (e.g., trisomy 21/18/13)

Design outcomes

Primary

Measure	Time frame
Correlation between buccal administration of colostrum and late onset sepsis	—

Secondary

Measure	Time frame
To detect whether administration of buccal colostrum will affect time to start oral feeding and time to reach full feeds	—

Countries

Egypt

Contacts

Public ContactEsraa Ahmed El Mazzahy

Lecturer of pediatrics and neonatology

dresraaelmazahy@gmail.com01223772676

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026