Clinical trial NCT06534632: Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants
Official title: Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Lead sponsor: General Organization for Teaching Hospitals and Institutes
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of infants with late-onset sepsis in each group
timeFrame: Up to 40 weeks corrected gestational age
Secondary outcomes:
measure: Mortality
timeFrame: Up to 40 weeks corrected gestational age
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mataria Teaching Hospital
Study officials:
affiliation: Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
name: Marwa Taha, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
name: Mai M Mostafa, M.D.
role: STUDY_DIRECTOR
affiliation: Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
name: Fifi Helmy, M.D.
role: STUDY_DIRECTOR
affiliation: Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
name: Sohaila A Abd El-Halim, M.D.
role: STUDY_DIRECTOR
References: