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

March 14, 2026 updated by: Dalia Mohamed Salah, Tanta University

Comparative Study of 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Neonatal Intensive Care Unit, Tanta University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colostrum Group
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
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.
Experimental: Chlorhexidine Group
Preterm neonates receiving oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity using sterile swabs.
Drug: Chlorhexidine Oral Care
Oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity of ventilated preterm neonates at scheduled intervals according to NICU protocol.
Experimental: Sodium Bicarbonate Group
Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs.
Other: Sodium Bicarbonate oral care
Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs.
Experimental: Control Group (Normal Saline)
Preterm neonates receiving routine oral care using sterile normal saline.
Other: Normal Saline Oral Care
Routine oropharyngeal care using sterile normal saline applied with sterile swabs at regular intervals during mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 28 days after initiation of mechanical ventilation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of mechanical ventilation up to 28 days.
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.
From initiation of mechanical ventilation until successful extubation, up to 28 days.
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.
From NICU admission until discharge, up to 60 days.
4.Neonatal Mortality
Time Frame: From NICU admission until discharge, up to 60 days
All-cause mortality among ventilated preterm neonates during NICU hospitalization.
From NICU admission until discharge, up to 60 days
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.
Baseline and up to 28 days after initiation of mechanical ventilation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Dalia Ayoub, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264MS499/2/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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