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Completed

NCT Number: NCT07482007

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

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

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Key information

Conditions

Ventilator-associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, Egypt

About this study

Randomized controlled trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Sodium Bicarbonate oral care

Other

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

Normal Saline Oral Care

Other

Routine oropharyngeal care using sterile normal saline applied with sterile swabs at regular intervals during mechanical ventilation.

Primary outcomes

  1. Incidence of Ventilator-Associated Pneumonia (VAP)

    Time frame: 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 outcomes

  1. 1.Time to Development of Ventilator-Associated Pneumonia

    Time frame: 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. 2.Duration of Mechanical Ventilation

    Time frame: 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. 3. Length of Neonatal Intensive Care Unit (NICU) Stay

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

    Total number of days the neonate remains admitted in the NICU.

  4. 4.Neonatal Mortality

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

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

  5. 5. Oropharyngeal Bacterial Colonization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jun 4, 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.

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