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

NCT07482007 | Completed DMC

• 1 other identifier: 36264MS499/2/24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilator-Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 1.Time to Development of Ventilator-Associated Pneumonia

  From initiation of mechanical ventilation up to 28 days.

• 2.Duration of Mechanical Ventilation

  From initiation of mechanical ventilation until successful extubation, up to 28 days.

• 3. Length of Neonatal Intensive Care Unit (NICU) Stay

  From NICU admission until discharge, up to 60 days.

• 4.Neonatal Mortality

  From NICU admission until discharge, up to 60 days

• 5. Oropharyngeal Bacterial Colonization

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

Study Arms (4)

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.

Other: Oropharyngeal Care with Colostrum

Chlorhexidine Group

EXPERIMENTAL

Preterm neonates receiving oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity using sterile swabs.

Drug: Chlorhexidine Oral Care

Sodium Bicarbonate Group

EXPERIMENTAL

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

Other: Sodium Bicarbonate oral care

Control Group (Normal Saline)

EXPERIMENTAL

Preterm neonates receiving routine oral care using sterile normal saline.

Other: Normal Saline Oral Care

Interventions

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.

Colostrum Group

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.

Chlorhexidine Group

Sodium Bicarbonate oral care OTHER

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

Sodium Bicarbonate Group

Normal Saline Oral Care OTHER

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

Control Group (Normal Saline)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• Dalia Ayoub

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 19, 2026
• Study Start: April 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2025-04

Locations

EG (1)