Oropharyngeal Care With Colostrum, Chlorohexidine and Sodium Bicarbonate in Preventing Ventilator-associated Pneumonia in Preterm Neonates

N/ACompletedNCT07482007

Tanta University80 enrolled

Overview

comparing the effect of oral care with colostrum, chlorohexidine and sodium bicarbonate in prevention of ventilator-associated pneumonia in preterm neonates.

Randomized controlled trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Ventilator-Associated Pneumonia

Interventions

Oropharyngeal Care with ColostrumOTHER

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.

Chlorhexidine Oral CareDRUG

Oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity of ventilated preterm neonates at scheduled intervals according to NICU protocol.

Sodium Bicarbonate oral careOTHER

Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, Egypt

Outcomes

Primary Outcomes

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

Time frame: Up to 28 days after initiation of mechanical ventilation.

Secondary Outcomes

1.Time to Development of Ventilator-Associated Pneumonia

Time interval between initiation of mechanical ventilation and the first diagnosis of ventilator-associated pneumonia.

Time frame: From initiation of mechanical ventilation up to 28 days.

2.Duration of Mechanical Ventilation

Total duration of invasive mechanical ventilation required by preterm neonates in each study group.

Time frame: 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.

Time frame: From NICU admission until discharge, up to 60 days.

4.Neonatal Mortality

All-cause mortality among ventilated preterm neonates during NICU hospitalization.

Time frame: 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.

Time frame: Baseline and up to 28 days after initiation of mechanical ventilation.

Data from ClinicalTrials.gov

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