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Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants

Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06534632
Enrollment
65
Registered
2024-08-02
Start date
2022-11-01
Completion date
2023-11-01
Last updated
2024-08-05

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

Conditions

Prematurity

Brief summary

This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.

Detailed description

The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria. The enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period. All infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes.

Interventions

OTHERMother's colostrum

Oropharyngeal administration of mother's colostrum

OTHERPlacebo

Oropharyngeal administration of sterile water

Sponsors

General Organization for Teaching Hospitals and Institutes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 24 Hours
Healthy volunteers
No

Inclusion criteria

* Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery * Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams

Exclusion criteria

* Infants with severe gastrointestinal malformations. * Infants with serious congenital anomalies or chromosomal abnormalities. * Infants with signs of early-onset sepsis. * Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.

Design outcomes

Primary

MeasureTime frameDescription
Number of infants with late-onset sepsis in each groupUp to 40 weeks corrected gestational agePositive blood cultures collected or clinical symptoms of sepsis after 72 hours of age

Secondary

MeasureTime frameDescription
MortalityUp to 40 weeks corrected gestational ageNumber of deaths in each group

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026