Oral Care With Breast Milk in Preterm Newborns Fed by Tube

Breastmilk Clinical Trial

Official title:

Oral Care With Breast Milk in Preterm Newborns Fed by Tube:A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129266
• Other study ID #: 13/38
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: April 2024
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube

Description:

Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 15, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

• -Staying in the neonatal intensive care unit
• Being fed by gavage
• Babies with no oral intake (nonperoral-NPO)
• Babies fed with breast milk and/or formula

Exclusion Criteria:

• Babies who are exclusively breastfed
• Cleft palate/lip
• Major congenital anomaly
• Intubated babies

Related Conditions & MeSH terms

• Breastmilk
• Oral Care

Intervention

Other:
• oral care with breastmilk
No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study	Oral care	from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.