Ventilator-Associated Pneumonia
Conditions
Brief summary
comparing the effect of oral care with colostrum, chlorohexidine and sodium bicarbonate in prevention of ventilator-associated pneumonia in preterm neonates.
Detailed description
Randomized controlled trial
Interventions
OTHEROropharyngeal Care with Colostrum
Application of small amounts of expressed maternal colostrum to the oral mucosa of ventilated preterm neonates using sterile swabs every 3-4 hours according to NICU oral care protocol.
Oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity of ventilated preterm neonates at scheduled intervals according to NICU protocol.
OTHERSodium Bicarbonate oral care
Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs.
OTHERNormal Saline Oral Care
Routine oropharyngeal care using sterile normal saline applied with sterile swabs at regular intervals during mechanical ventilation.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Preterm neonates requiring mechanical ventilation will be randomly assigned into four parallel groups to receive different types of oropharyngeal care (colostrum, chlorhexidine, sodium bicarbonate or saline). Oral care will be performed according to a standardized NICU protocol at regular intervals during mechanical ventilation. The incidence of ventilator-associated pneumonia will be compared among the four groups.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Preterm neonates with gestational age less than 37 weeks. Neonates admitted to the Neonatal Intensive Care Unit (NICU). Neonates requiring invasive mechanical ventilation for more than 48 hours. Age ≤ 72 hours at time of enrollment. Written informed consent obtained from parents or legal guardians.
Exclusion criteria
* Neonates with major congenital anomalies. Neonates with congenital airway malformations. Presence of congenital pneumonia at birth. Neonates with severe gastrointestinal malformations preventing enteral feeding. Neonates who develop early-onset sepsis at admission. Neonates with contraindications to oral care procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ventilator-Associated Pneumonia (VAP) | Up to 28 days after initiation of mechanical ventilation. | To compare the incidence of ventilator-associated pneumonia among preterm neonates receiving different types of oropharyngeal care (colostrum, chlorhexidine, sodium bicarbonate, or normal saline). Diagnosis of VAP will be based on clinical signs, radiological findings, and microbiological evidence according to NICU infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1.Time to Development of Ventilator-Associated Pneumonia | From initiation of mechanical ventilation up to 28 days. | Time interval between initiation of mechanical ventilation and the first diagnosis of ventilator-associated pneumonia. |
| 2.Duration of Mechanical Ventilation | From initiation of mechanical ventilation until successful extubation, up to 28 days. | Total duration of invasive mechanical ventilation required by preterm neonates in each study group. |
| 3. Length of Neonatal Intensive Care Unit (NICU) Stay | From NICU admission until discharge, up to 60 days. | Total number of days the neonate remains admitted in the NICU. |
| 4.Neonatal Mortality | From NICU admission until discharge, up to 60 days | All-cause mortality among ventilated preterm neonates during NICU hospitalization. |
| 5. Oropharyngeal Bacterial Colonization | Baseline and up to 28 days after initiation of mechanical ventilation. | Presence and type of bacterial colonization detected in oropharyngeal swab cultures among ventilated preterm neonates. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORDalia Ayoub
Tanta University
Outcome results
None listed