Clincosm LogoSign in Get a demo

Oral Care With Breast Milk in Preterm Newborns Fed by Tube

Sponsor
Karabuk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129266
Collaborator
(none)
64
Enrollment
2
Arms
3.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: oral care with breastmilk
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Oral Care With Breast Milk in Preterm Newborns Fed by Tube:A Randomized Controlled Study
Anticipated Study Start Date :
Nov 5, 2023
Anticipated Primary Completion Date :
Jan 5, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Weeks to 33 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karabuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayse Cuvadar, Assistant Professor, Karabuk University
    ClinicalTrials.gov Identifier:
    NCT06129266
    Other Study ID Numbers:
    • 13/38
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 13, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayse Cuvadar, Assistant Professor, Karabuk University
    breastmilk
    oral care
    newborn

    Study Results

    No Results Posted as of Nov 13, 2023