Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants

March 4, 2026 updated by: Nada Youssef, Ain Shams University

The Role of Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants

70 Neonates in neonatal intensive care unit , ain shams university , children hospital

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

preterms less than 34 weeks gestational age , with moderate to severe respiratory distress syndrome , available maternal milk and delivered by cesarean section

Study Type

Interventional

Enrollment (Actual)

70

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
      • Cairo, Egypt
        • Faculty of Medicine Ain Shams University

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Gestational age less than 34 weeks
  2. Patients with moderate to severe respiratory distress syndrome on invasive mechanical ventilation in the 1st 3 days of life
  3. Available maternal breast milk
  4. Patients delivered by caesarean section

Exclusion Criteria:

  1. Patients with no available maternal breast milk
  2. Preterms who had a surgical procedure
  3. Patients with inborn error of metabolism
  4. Patients with major congenital anomalies
  5. Patients with hypoxic ischemic enceohalopathy
  6. Patients delivered by vaginal delivery

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: maternal milk oral care group
Other: oral care with maternal milk
oral care with maternal milk every 3 hours
Placebo Comparator: sodium bicarbonate oral care group
Other: oral care with sodium bicarbonate
oral care with sodium bicarbonate every 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of mechanical ventilation , length of hospital stay and mortality
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of ventilator associated pneumonia , late onset sepsis and necrotizing enterocolitis
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

June 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral care with maternal milk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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