Faculty of medicine Ain shams university
Cairo, Egypt
Completed
NCT Number: NCT07451964
Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants
70 Neonates in neonatal intensive care unit , ain shams university , children hospital
Completed
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Notify MeKey information
Age range
0 hour–3 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
preterms less than 34 weeks gestational age , with moderate to severe respiratory distress syndrome , available maternal milk and delivered by cesarean section
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Gestational age less than 34 weeks
- Patients with moderate to severe respiratory distress syndrome on invasive mechanical ventilation in the 1st 3 days of life
- Available maternal breast milk
- Patients delivered by caesarean section
Exclusion criteria
- Patients with no available maternal breast milk
- Preterms who had a surgical procedure
- Patients with inborn error of metabolism
- Patients with major congenital anomalies
- Patients with hypoxic ischemic enceohalopathy
- Patients delivered by vaginal delivery
Treatment and study plan
oral care with maternal milk
Otheroral care with maternal milk every 3 hours
oral care with sodium bicarbonate
Otheroral care with sodium bicarbonate every 3 hours
Primary outcomes
-
duration of mechanical ventilation , length of hospital stay and mortality
Time frame: 6 months
Secondary outcomes
-
incidence of ventilator associated pneumonia , late onset sepsis and necrotizing enterocolitis
Time frame: 6 months
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Official study title
The Role of Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Mar 5, 2026
- Registry last updated
- Mar 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.