The Efficacy of Systematic Oral Feeding Education Program (SOFEP)

National Taiwan University

Status: Not yet enrolling

Conditions: Congenital Heart Disease

Treatments: Other: Systematic Oral Feeding Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06763497

202412004RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

The control group - received routine care

No Intervention group

Description:

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.

experimental group - systematic oral feeding education program

Other group

Description:

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.

Treatment:

Other: Systematic Oral Feeding Education Program