Oral Care With Breast Milk in Preterm Newborns Fed by Tube

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

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

Study Overview

• Status: Completed
• Conditions: Breastmilk; Oral Care
• Intervention / Treatment: Other: oral care with breastmilk

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22100
    • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention (Oral care with breastmilk) group; 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.	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.; Other Names: routine maintenance
No Intervention: Routine maintenance group; No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Karabuk University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): April 23, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: newborn; oral care; breastmilk
• Other Study ID Numbers: 13/38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No