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comparing the effect of oral care with colostrum, chlorohexidine and sodium bicarbonate in prevention of ventilator-associated pneumonia in preterm neonates.
Randomized controlled trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colostrum Group | Experimental | Preterm neonates receiving oropharyngeal care with expressed maternal colostrum applied to the oral mucosa using sterile swabs at regular intervals during mechanical ventilation. |
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| Chlorhexidine Group | Experimental | Preterm neonates receiving oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity using sterile swabs. |
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| Sodium Bicarbonate Group | Experimental | Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs. |
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| Control Group (Normal Saline) | Experimental | Preterm neonates receiving routine oral care using sterile normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oropharyngeal Care with Colostrum | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ventilator-Associated Pneumonia (VAP) | 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 | Up to 28 days after initiation of mechanical ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| 1.Time to Development of Ventilator-Associated Pneumonia | Time interval between initiation of mechanical ventilation and the first diagnosis of ventilator-associated pneumonia. | From initiation of mechanical ventilation up to 28 days. |
| 2.Duration of Mechanical Ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalia Ayoub | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Tanta University Children's Hospital | Tanta | Egypt |
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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.
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| Chlorhexidine Oral Care | Drug | Oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity of ventilated preterm neonates at scheduled intervals according to NICU protocol. |
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| Sodium Bicarbonate oral care | Other | Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs. |
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| Normal Saline Oral Care | Other | Routine oropharyngeal care using sterile normal saline applied with sterile swabs at regular intervals during mechanical ventilation. |
|
Total duration of invasive mechanical ventilation required by preterm neonates in each study group. |
| From initiation of mechanical ventilation until successful extubation, up to 28 days. |
| 3. Length of Neonatal Intensive Care Unit (NICU) Stay | Total number of days the neonate remains admitted in the NICU. | From NICU admission until discharge, up to 60 days. |
| 4.Neonatal Mortality | All-cause mortality among ventilated preterm neonates during NICU hospitalization. | From NICU admission until discharge, up to 60 days |
| 5. Oropharyngeal Bacterial Colonization | Presence and type of bacterial colonization detected in oropharyngeal swab cultures among ventilated preterm neonates. | Baseline and up to 28 days after initiation of mechanical ventilation. |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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