Oral Care With Breast Milk in Preterm Newborns Fed by Tube

Not Applicable

Completed

• Conditions: Oral Care; Breastmilk
• Interventions: Other: oral care with breastmilk

• Registration Number: NCT06129266
• Lead Sponsor: Karabuk University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Study Start: 2024-01-15
• Primary Completion: 2024-04-23
• Status Verified: 2024-06
• Study Completion: 2024-06-21
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
İntervention (Oral care with breastmilk) group	oral care with breastmilk	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.

Primary Outcome Measures

Name	Time	Method
Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study	from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.	Oral care

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Turkey