Mataria Teaching Hospital
Cairo, Egypt
NCT Number: NCT06534632
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.
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Notify Me1 hour–24 hour
All sexes
Interventional
Not applicable
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oropharyngeal administration of mother's colostrum
Oropharyngeal administration of sterile water
Time frame: Up to 40 weeks corrected gestational age
Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age
Time frame: Up to 40 weeks corrected gestational age
Number of deaths in each group
General Organization for Teaching Hospitals and Institutes
Other
Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants
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