Oral Care With Breast Milk in Preterm Newborns Fed by Tube

NCT ID: NCT06129266

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-06-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Breastmilk Oral Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

oral care with breastmilk

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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routine maintenance

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Cuvadar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Trakya University

Edirne, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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13/38

Identifier Type: -

Identifier Source: org_study_id

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