The Efficacy of Systematic Oral Feeding Education Program (SOFEP)

January 1, 2025 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

The Efficacy of Systematic Oral Feeding Education Program (SOFEP) on Feeding Techniques, Caregiver Stress, and Infant Feeding Skills in Caregivers of Infants With Congenital Heart Disease After Surgery

After the intervention of Systematic Oral Feeding Education Program:

  1. The feeding techniques scores of the main caregivers in the experimental group will be higher than those in the control group.
  2. The caregiving stress scores of the main caregivers in the experimental group will be lower than those in the control group.
  3. The feeding skill scores of infants in the experimental group will be higher than those in the control group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will adopt a quasi-experimental design and will purposively and consecutively sample participants from the pediatric ward of a medical center in northern Taiwan. Enrollment will be conducted based on the inclusion and exclusion criteria of the study. To avoid contamination between the experimental and control groups, recruitment for the control group will be completed before recruitment for the experimental group begins. Each group will undergo a 3-month recruitment period or until 30 participants have been enrolled in each group.

Each participant will be followed for 14 days. On the enrollment day, after obtaining informed consent, a pretest will be conducted. This includes completing the "Participant Demographic Information Form" and the "Parenting Stress Index" and having the primary caregiver's infant feeding practices observed by the researcher. The caregiver's feeding techniques will be assessed using the "Oral Feeding Techniques Scale," and the infant's oral feeding performance will be evaluated using the "Early Feeding Skills Assessment Scale." Additionally, participants will complete a daily feeding log for the 14-day study period. On the final day, posttests will include the same self-reported questionnaires and observation-based assessments as the pretest.

The control group will receive standard ward care and will complete the posttest on the 14th day. The experimental group will receive 11 intervention sessions during the study period. The first intervention will occur immediately after the pretest and will involve a systematic oral feeding education program, including guided feeding techniques and practical feeding demonstrations. During the feeding session, caregivers' practices will be recorded on video. These recordings will then be reviewed with the caregiver to identify areas for improvement.

The remaining 10 intervention sessions will take place daily on days 2-4, 6-9, and 11-13, during which the researcher will observe the primary caregiver's feeding practices, provide assistance, and offer tailored suggestions. On the 14th day, the experimental group will complete the same posttest assessments as the control group.

Statistical analysis will be conducted using SPSS Statistics (version 22.0). Independent sample t-tests, paired sample t-tests, and generalized estimating equations (GEE) will be employed to evaluate the effects of the systematic oral feeding education program on the primary caregiver's feeding techniques, caregiving stress, and the infant's oral feeding skills.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Infants with congenital heart disease and their primary caregivers who meet the following conditions will be admitted:

  1. Infant Criteria:

    Inclusion Criteria:

    • Infants diagnosed with congenital heart disease and younger than 12 months at the time of enrollment.
    • Infants unable to meet their required oral feeding volume (10% of body weight = 100 ml/kg) at the time caregiving begins.
    • Infants who have undergone open-heart surgery with cardiopulmonary bypass.
    • Infants assessed by physicians as ready to begin oral feeding training.

    Exclusion Criteria:

    • Corrected gestational age less than 32 weeks.
    • Infants with congenital conditions involving the mouth, throat, or esophagus (e.g., cleft palate, esophageal atresia with tracheoesophageal fistula).
    • Infants with congenital central nervous system disorders.
    • Infants consuming food via methods other than bottle feeding (e.g., spoon-feeding, complementary food, or solid food).
    • Infants whose primary feeding method is breastfeeding directly at the breast.
  2. Primary Caregiver Criteria

Inclusion Criteria:

  • Caregivers aged 18 years or older.
  • The infant's legal father or mother.
  • Caregivers who participate in at least two oral feeding sessions per day for the infant.

Exclusion Criteria:

  • Caregivers unable to complete self-administered questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The control group - received routine care
On the day of receipt of the case, after completing the informed consent form, the pre-test was also completed, including asking the subjects to complete the "Basic Case Information Form" and the "Parenting Stress Scale", and the researcher observed the primary caregiver feeding the baby. , use the "Oral Feeding Techniques Scale" to evaluate the caregiver's feeding techniques and the "Infant Feeding Skills Assessment Scale" to evaluate the infant's oral feeding status. In addition, the subjects were asked to fill in the feeding record form every day during the 14-day period, and complete the aforementioned self-report scale and observation evaluation form on the day the case was closed. The control group received routine care in the ward and took the post-test of the scale on the 14th day.
Other: experimental group - systematic oral feeding education program
The experimental group conducted 11 interventions before and after completing the primary caregiver's oral feeding techniques, caregiving stress and infant feeding skills. The first time was after completing the pre-test, a systematic oral feeding education program was used to provide feeding skills guidance and Practical feeding guidance, and assisting in video recording during the actual feeding operation. After completion, the video was used to discuss possible corrections. The remaining 10 interventions were conducted on days 2-4, 6-9, and 11-13 to observe the main care every day. The patient's feeding status was reviewed once and assistance and suggestions were provided. On the 14th day, the patient completed the relevant scale post-test.
Other: Systematic Oral Feeding Education Program
The experimental group will receive 11 intervention sessions during the study period. The first intervention will occur immediately after the pretest and will involve a systematic oral feeding education program, including guided feeding techniques and practical feeding demonstrations. During the feeding session, caregivers' practices will be recorded on video. These recordings will then be reviewed with the caregiver to identify areas for improvement.The remaining 10 intervention sessions will take place daily on days 2-4, 6-9, and 11-13, during which the researcher will observe the primary caregiver's feeding practices, provide assistance, and offer tailored suggestions. On the 14th day, the experimental group will complete the same posttest assessments as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oral feeding techniques scale for primary caregivers early feeding skills assessment EFS parenting stress index, fourth edition short form, PSI-4-SF
Time Frame: on the 14th day

The researcher developed a self-designed scale based on systematic oral feeding education program, expert opinions, and relevant literature to evaluate the primary caregiver's oral feeding techniques. The scale comprises four main sections:

  1. Preparation before feeding (including oral stimulation).
  2. Feeding process (including oral support).
  3. Provision of developmental feeding support.
  4. Observation of dehydration warning signs. The scale consists of 21 items. When the caregiver's feeding behavior or response aligns with the descriptions in the items, it is marked as "Yes" and awarded 1 point. If not, it is marked as "No" and receives 0 points. The total score ranges from 0 to 21, with higher scores indicating better feeding techniques.

The evaluation is conducted by observing the caregiver during actual feeding sessions (or reviewing recorded feeding videos) and scoring based on their observed behaviors.
on the 14th day
early feeding skills assessment, EFS
Time Frame: on the 14th day

The EFS consists of 24 items that assess infant feeding skills across three domains:

  1. Preparation for oral feeding (3 items: motor behavior, state, and oral behaviors when given a pacifier).
  2. Feeding process evaluation, which des: breathing regulation (5 items), coordination of oral movements (4 items), swallowing coordination (4 items), sustaining engagement (2 items), and physiological stability (4 items).
  3. Post-feeding tolerance (2 items: state and energy level). Each item is scored on a scale of 1 to 3, where a score of 1 indicates problems, and a score of 3 indicates no problems. The total score ranges from 24 to 72, with higher scores indicating better feeding skills.

The assessment identifies both the infant's abilities and areas of difficulty.
on the 14th day
parenting stress index, fourth edition short form, PSI-4-SF
Time Frame: on the 14th day

This scale was originally developed to evaluate parenting stress in parents of children. Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) consists of 36 items selected from the Long Form and is divided into three subscales:

  1. Parental Distress (Items 1-12): Assesses the distress experienced by individuals in their role as a parent.
  2. Parent-Child Dysfunctional Interaction (Items 13-24): Evaluates stress arising from interactions and mutual influences between parents and children.
  3. Difficult Child (Items 25-36): Assesses behavioral characteristics of the child that contribute to stress in the parent-child system.

The scale uses a 5-point Likert scale for scoring, ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). The total score ranges from a minimum of 36 to a maximum of 180, with higher scores indicating greater levels of parenting stress.
on the 14th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: YA-HAN LIN, MS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 19, 2025

Study Completion (Estimated)

December 19, 2025

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202412004RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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