Oral Care With Breast Milk in Preterm Newborns Fed by Tube

NCT06129266 | Completed

• 1 other identifier: 13/38
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breastmilk; Oral Care

Keywords

breastmilk; oral care; newborn

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

İntervention (Oral care with breastmilk) group

EXPERIMENTAL

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

Routine maintenance group

NO INTERVENTION

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

Interventions

oral care with breastmilk OTHER

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

Also known as: routine maintenance

İntervention (Oral care with breastmilk) group

Eligibility Criteria

• Age: 28 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Trakya University

Edirne, 22100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 13, 2023
• Study Start: January 15, 2024
• Primary Completion: April 23, 2024
• Study Completion: June 21, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

TU (1)