Oral Care With Maternal Milk in Mechanically Ventilated P... | NCT07451964

Studies
Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants

NCT07451964

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 6, 2026Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Role of Oral Care in Mechanically Ventilated Preterm Infants

Interventions

oral care with maternal milk
oral care with sodium bicarbonate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Nov 1, 2025Actual

Completion Date

Nov 30, 2025Actual

First Submitted Date

Mar 2, 2026

First Submission Date that Met QC Criteria

Mar 2, 2026

First Posted Date

Mar 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2026

Last Update Posted Date

Mar 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
maternal milk oral care group	Active Comparator		Other: oral care with maternal milk
sodium bicarbonate oral care group	Placebo Comparator		Other: oral care with sodium bicarbonate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral care with maternal milk	Other	oral care with maternal milk every 3 hours	maternal milk oral care group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with no available maternal breast milk
Preterms who had a surgical procedure
Patients with inborn error of metabolism
Patients with major congenital anomalies
Patients with hypoxic ischemic enceohalopathy
Patients delivered by vaginal delivery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Hours

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine Ain shams university		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017693	Sodium Bicarbonate

Ancestor Terms

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic

Browse Leaves

Not provided

Browse Branches

Not provided