search
Back to results

Effect of Supplemental Feeding Tube Devices in Breastfeeding Success and Mother's Breastfeeding Self-Efficacy

Primary Purpose

Breastfeeding, Feeding Disorder Neonatal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supplemental Feeding Tube Device
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding focused on measuring neonatal feeding, breastfeeding, supplemental feeding tube device

Eligibility Criteria

32 Weeks - 35 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Postmenstrual age 32 and 35 weeks of gestation, Over 1500 g, Switching to oral feeding after feeding with orogastric tube, Who has been breastfed during gavage feeding, Those who have not completed the first 24 hours in the transition from oragastric tube feeding to the oral feeding process, Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and breathing during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli), The mother's willingness to breastfeed her baby, Premature babies of parents who volunteered to participate in the study will be included. Exclusion Criteria: Having diseases other than being premature Able to successfully take the breast in the first attempt, Congenital anomaly, Chromosomal disorders, Having sepsis With intracranial bleeding, Those with a very low birth weight below 1500 g and Less than 32nd gestational week, Premature babies older than 35 weeks of gestation will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    Control

    Arm Description

    The babies in the experimental group are fed 3 meals from the day after the decision to switch to oral feeding, with supplemental feeding tube device(SFTD) (09:00-12:00-15:00) and other meals with a bottle.

    The babies in the control group, on the other hand, will be fed 3 meals a day (09:00-12:00-15:00) after the decision to switch to oral feeding, which is the routine feeding method of the intensive care unit, and with a bottle for other meals in the same way.

    Outcomes

    Primary Outcome Measures

    LATCH a breastfeeding charting system and documentation tool
    LATCH is a diagnostic tool whose scoring system is similar to the Apgar score system. The scale consists of five evaluation criteria. The LATCH diagnostic tool is formed from the English initials of these five criteria. For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0,1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The higher the score obtained from the scale, the higher the success of breastfeeding. In the research, the mother and her baby will be observed and evaluated while breastfeeding.
    Breastfeeding Self-Efficacy Short Form Scale
    The scale is in 5-point Likert type and the items of the scale are evaluated by grading from 1 "I am not sure" to 5 "I am always sure". The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score on the scale indicates higher breastfeeding self-efficacy.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2023
    Last Updated
    April 7, 2023
    Sponsor
    Medipol University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05802095
    Brief Title
    Effect of Supplemental Feeding Tube Devices in Breastfeeding Success and Mother's Breastfeeding Self-Efficacy
    Official Title
    The Effect of Supplemental Feeding Tube Devices Used in Preterms on Baby's Breastfeeding Success and Mother's Breastfeeding Self-Efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    December 15, 2024 (Anticipated)
    Study Completion Date
    February 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medipol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers. In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.
    Detailed Description
    Premature babies have to cope with many problems in the neonatal intensive care unit (NICU) in the postnatal period, and feeding problems are the leading of these problems. Oral feeding of premature infants is a complex and dynamic process consisting of the interaction of oral-motor, neurological, cardiorespiratory and gastrointestinal systems. Because they are anatomically and physiologically immature, they often cannot coordinate their sucking, swallowing and respiration for oral feeding, and they often have difficulty in oral feeding. Therefore, feeding premature babies in the NICU is provided by an orogastric or nasogastric tube. Continuing the feeding with the gavage method for a long time causes a delay in the acquisition of the motor skills required for oral feeding. Therefore, premature babies should be switched to oral feeding when they are physiologically ready. It is known that growth and developmental retardation are seen in premature babies if appropriate and adequate nutrition is not provided on time. The most basic criterion sought in the transition to oral feeding in premature babies is the development of feeding skills. Different oral stimulus interventions have been developed to support and strengthen the development of oral-motor functions, create sufficient suction power, and start oral nutrition earlier. Tactile/kinesthetic stimulation, oral stimulation, swallowing exercises, non-nutritive sucking, gentle pressure on the cheeks, lips, chin and palate are among the most common sensorimotor interventions. It is reported that these interventions accelerate the transition time to oral feeding. Successful sucking transition from gavage to full oral feeding is one of the most important determinants of both discharges from the NICU and the growth and development of premature infants. This study will evaluate the effect of the breastfeeding support system used in premature babies on the baby's sucking success and the mother's breastfeeding self-efficacy. The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers. In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breastfeeding, Feeding Disorder Neonatal
    Keywords
    neonatal feeding, breastfeeding, supplemental feeding tube device

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised Controlled Clinical Trial
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    The babies in the experimental group are fed 3 meals from the day after the decision to switch to oral feeding, with supplemental feeding tube device(SFTD) (09:00-12:00-15:00) and other meals with a bottle.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The babies in the control group, on the other hand, will be fed 3 meals a day (09:00-12:00-15:00) after the decision to switch to oral feeding, which is the routine feeding method of the intensive care unit, and with a bottle for other meals in the same way.
    Intervention Type
    Device
    Intervention Name(s)
    Supplemental Feeding Tube Device
    Intervention Description
    One end of the catheter is in such a way that milk comes into the bottle. The tip of the feeding catheter can be fixed to the mother's breast with a plaster so that it is in the baby's mouth. The tip of the catheter is placed inside the baby's mouth while the baby is sucking on its mother. While the mother is breastfeeding, milk is supplied to the baby from both the mother and the bottle. The baby will continue to suckle as he feels that plenty of milk is coming. To increase the flow of milk from the bottle, the mother hangs the bottle around her neck with the teat side down. The higher the bottle or milk container is held, the greater the flow of milk. It is an easy and safe method.
    Primary Outcome Measure Information:
    Title
    LATCH a breastfeeding charting system and documentation tool
    Description
    LATCH is a diagnostic tool whose scoring system is similar to the Apgar score system. The scale consists of five evaluation criteria. The LATCH diagnostic tool is formed from the English initials of these five criteria. For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0,1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The higher the score obtained from the scale, the higher the success of breastfeeding. In the research, the mother and her baby will be observed and evaluated while breastfeeding.
    Time Frame
    1 hours
    Title
    Breastfeeding Self-Efficacy Short Form Scale
    Description
    The scale is in 5-point Likert type and the items of the scale are evaluated by grading from 1 "I am not sure" to 5 "I am always sure". The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score on the scale indicates higher breastfeeding self-efficacy.
    Time Frame
    1 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Weeks
    Maximum Age & Unit of Time
    35 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Postmenstrual age 32 and 35 weeks of gestation, Over 1500 g, Switching to oral feeding after feeding with orogastric tube, Who has been breastfed during gavage feeding, Those who have not completed the first 24 hours in the transition from oragastric tube feeding to the oral feeding process, Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and breathing during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli), The mother's willingness to breastfeed her baby, Premature babies of parents who volunteered to participate in the study will be included. Exclusion Criteria: Having diseases other than being premature Able to successfully take the breast in the first attempt, Congenital anomaly, Chromosomal disorders, Having sepsis With intracranial bleeding, Those with a very low birth weight below 1500 g and Less than 32nd gestational week, Premature babies older than 35 weeks of gestation will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hilal Berber Çiftci
    Phone
    00905447604184
    Email
    hilalberber1@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma Bozdağ
    Organizational Affiliation
    Harran University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34784787
    Citation
    Celik F, Sen S, Karayagiz Muslu G. Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):891-900. doi: 10.1177/10547738211058312. Epub 2021 Nov 16.
    Results Reference
    background

    Learn more about this trial

    Effect of Supplemental Feeding Tube Devices in Breastfeeding Success and Mother's Breastfeeding Self-Efficacy

    We'll reach out to this number within 24 hrs